circabc.europa.eu · Web viewOn the other hand, naming “bioethanol and biodiesel” may cause further confusion between activities of production of basic chemical constituents and

Data gathering and impact assessment for a possible technical review of the IPPC Directive – Part 2

Fact sheet A3 Chemical industry

Potential amendment A3: Possible changes to the current provisions of Annex I of the IPPC Directive on Chemical industry: Biological processing, biofuels and pharmaceutical intermediates

Status: final – 12/09/2007

1. Issue

Aim of the study: The present work intends to evaluate the possible changes to the provisions of Article 4 of the IPPC Directive Annex I on chemical industry, in order to clarify three specific interpretation issues and harmonise the permitting practices in the EU-27.

The work is based on a background literature survey, discussions with relevant industry and on the responses of the Member States to the questionnaire. It also takes into account the comments of the Advisory Group members on the draft final report.

Background: In the course of the first round of BREF-writing and in the implementation phase of the IPPC Directive, Member States and sector organisations have pointed at some areas of possible misinterpretation regarding Annex I §4, namely:

Biological processing may be used in various sub-sectors of §4, while it is only mentioned under ‘4.5 Installations using a chemical or biological process for the production of basic pharmaceutical products’.

Production of biofuels is currently not explicitly covered under the IPPC Directive. However, many Member States consider them to be covered as organic chemicals, while others see that bioethanol, and to a lesser extent biodiesel, are not covered by the Annex I.

§4.5 covers explicitly the “production of basic pharmaceutical chemicals”. However, the work of the IEG Guidance sub-group suggested that different interpretations exist concerning the extent to which pharmaceutical intermediates are covered by this article and/or articles 4.1 and 4.2.

Issue summary: The following issues will be further clarified in this fact sheet:

To what extent biological processes are currently covered by the article 4 and what are the clarification options concerning their coverage?

What is the current position of ‘production of biofuels’ and what are the clarification options concerning their coverage?

To what extent pharmaceutical intermediates are currently covered by the article 4 and what are the clarification options concerning their coverage under 4.1, 4.2 and 4.5?

The issue of biofuels is partially linked to the ‘biological processing’ issue, as part of the biofuel (bioethanol) is produced by fermentation, i.e. by a biological process. On the other hand, the production of biodiesel is clearly a chemical process (esterification).

The three issues of this fact sheet, “biological processing”, “biofuels” and “pharmaceutical intermediates”, will be described and assessed in sections 2, 3 and 4, respectively. In all the sections the sub-section x.1 describes the current practice; sub-

VITO and BIO, with Institute for European Environmental Policy and IVM 1



section x.2 describes options for clarifying the issue; and the impacts of these options are analysed in sub-section x.3.

As part of the data gathering, a questionnaire covering all the issues was sent to the Advisory Group members. In addition, a questionnaire on biofuels was distributed to the national associations of bioethanol sector, with the help of the European federation European Union of Ethanol Producers (UEPA) and European Bioethanol Fuel Association (eBIO). European Biodiesel Board (EBB) was also consulted. Issues were also discussed with DG Environment and DG Enterprise.

2. Biological processing

2.1. Current practice regarding biological processing

a. Scope of the sector

The use of biological processes within chemical industry is part of ‘industrial biotechnology’ (also called ‘white biotechnology’). Biological processes in the production of chemicals involve the use of living micro-organisms or their purified enzymes as biocatalysts. This often avoids the use of toxic catalysts and extreme process conditions, although other waste streams may be produced instead. Enzymes can be used “in solution or fixed on a substrate, or as part of a polyfunctional enzymatic system, e.g. in living cells, free in a reaction medium or fixed on a substrate” [EC 2006c].

‘Fermentation’ is a key process in industrial biotechnology. Fine Organic Chemicals BREF [EC 2006c] defines it as “a chemical change induced by a living organism or enzyme, specifically bacteria, or the micro-organism occurring in yeast, moulds, or fungi to produce a specific product”. Such definition highlights well the fine line that separates ‘biological processes’ from ‘chemical’ ones.

Biological processes used in the production of chemicals, other than pharmaceuticals, include:

Fermentation in the production of bioethanol (see also Section 3.1) Fermentation in the production of the raw material for bio-based polymers (e.g.

polylactic acid, PLA) Biological process for producing pure S-chloropropionic acid:

Avecia (United Kingdom) has developed a biological process for producing pure S-chloropropionic acid, which is an intermediate chemical used in the synthesis of certain herbicides. Their biological process is less energy intensive than the conventional chemical procedures and it avoids the use of additional chemicals. [OECD 2001]

Biocatalysis in the production of polyester: Baxenden Chemicals (United Kingdom) has developed a biological process that uses the enzyme lipase from the bacterium Candida antarctica to catalyse the polymerization reaction in the production of certain polyesters. This involves much lower temperature (60 °C) than the conventional chemical process (200 °C) and the use of either a titanium or tin based catalyst with solvents and inorganic acid is avoided. The bioprocess also yields a more uniform and thus more valuable product. [OECD 2001]




Biological processes play a very important role in the manufacture of technical enzymes themselves. Technical enzymes include products for the detergent industry and other technical enzymes e.g. for the starch, textile and fuel ethanol industries. The production is based on modern biotechnology using bacteria and moulds. The finished technical enzyme product is in liquid or dried (powder or grains) form.

b. Size and structure of the sector

Bioethanol production is further discussed within Section 3.1 on biofuels.

At present, biological processes (e.g. fermentation and enzymatic processes) are commonly used in the fine chemicals sector, to produce for example vitamins, pharmaceutical intermediates and flavours. They are also making their first inroads into larger volume segments such as polymers, bulk chemicals and biofuels, and many other industrial sectors where they are expected to have increasing applications.

Large scale biological processing is used in ethanol production (for biofuel and industrial purposes) at least in 20 MS (Annex D).

The bioplastics sector registers continuous growth. According to European Bioplastics1, pan-European consumption of bioplastics in 2003 was at 40000 tonnes. However the European bio-based polymer production has only very recently begun. Hycail, an enterprise from the Netherlands, has recently started operating a PLA plant which is to produce 50000 tonnes per year once the final phase of upgrading is complete. Procter & Gamble Chemicals is currently planning to set up a fermentative production of polyhydroxyalkanoates (PHA, a biobased type of polyester) in Europe. [IBAW 2005]

Bio-based polymers are an emerging sector and the production is expected to increase in the future. The total technical substitution potential, which can be derived from the material property set of each bio-based polymer and its petrochemical equivalent polymer is estimated at 15.4 million tonnes for EU-15, or 33% of the total current (2005) polymer production. However, a more detailed analysis taking into account economic, social, ecological and technological influencing factors lead to an estimated maximum of 1 million tonnes by 2010. [EC 2005]

Important production of technical enzyme takes place in Europe and the world’s largest enzyme plant employing 600 people is located in Kalunborg, Denmark [Novozymes]. It has not been possible to quantify the total production, but this may also not provide a good picture of the enzyme production processes as typically the enzymes quantities used in a process are relatively small. Consequently the absolute production volumes are also smaller than for many basic chemicals. Enzyme production takes place in a number of other MS, such as Finland, Sweden and the NL.

According to [Roos, P.] over 200 installations in the Netherlands use biological processing in the production of chemicals. Around 20 companies produce bio-based

1 The association "European Bioplastics" is the European branch association representing industrial manufacturers, processors and users of bioplastics and biodegradable polymers (BDP) and their derivative products.




polymers2, often as a division/part of large industries like DSM, Cargill, Dow and Avebe. The Netherlands has several hundreds installations producing technical enzymes (e.g. for detergents, food and cosmetic industries). Again, these installations are mostly divisions or parts of larger industries, such as DSL, Procter&Gamble and Unilever.

In Luxembourg, there is one installation of Dupont that produces films by bio-polymerisation. [Geimer, C.]

It is likely that the development of integrated diversified biorefineries - integrated cluster of industries, using a variety of different technologies to produce chemicals, pulp and paper, biofuels, food ingredients and power from biomass raw materials – will further blur the distinction between chemical and biological processes. As agricultural resources can substitute for fossil oil based raw materials, biological processes can be used to replace conventional chemical processes. [EuropaBio 2006]

Recent reports predict annual growth rates of nearly 5% for fermentation products (compared to 2-3% for overall chemical production) in the coming years. McKinsey & Company predicts that by 2010 bio-based (from bio-based feedstocks and/or by biological processes) products will account for 10 percent of sales within the chemical industry, accounting for $125 billion in value. Already, as of 2005, bio-based products accounted for 7 percent of sales and $77 billion in value within the chemical sector, and different studies agree that these products will play an increasingly significant role in the chemical and other manufacturing industries in the future. [EC 2003; EuropaBio 2006]

c. Environmental impacts

Compared to conventional chemical processing, biological processes are often more efficient and less energy-intensive. [EuropaBio 2006] Yet, biological processes are not emission free.

For example, in fermentation processes, water is used in both processes and cleaning operations, typically giving rise to effluents with high organic and nutrient loads. An example existing installation in Finland, which produces industrial enzymes by fermentation, has a COD load of 4767 mg/l and phosphorus of 110 mg/l before treatment [Ympäristökeskus 2003]. These are rather high loads, for example in comparison with many of the organic fine chemicals reference plants in the OFC BREF [2006b].

The OFC BREF [EC 2006c] lists the main waste streams from fermentation processes as:• biomass, possibly containing filtration auxiliaries• filtered broth, possibly containing precipitation auxiliaries• exhaust gas from seed and fermentation stages, containing broth aerosol, possibly being malodorous • VOC from solvent use (used e.g. in the purification of enzymes)• large volumes of waste water streams [EC 2006c].

Typically heat and steam are required in the processes and their production on-site may result in direct air emissions from combustion processes.

2 Bio-based polymers may be produced by both biological and chemical processing; no details were available on the production methods for the twenty installations.




On environmental impacts of biological processing, see also section 2.2(c) regarding bioethanol.

d. Techniques for prevention or reduction of environmental impacts

The techniques for prevention or reduction of environmental impacts applicable to e.g. fermentation are elaborated in OFC BREF; an overview of applied abatement techniques is provided in Figure 1 [EC 2006c].

Figure 1 – Applied abatement techniques for the waste streams from fermentation [EC 2006c]

Exhaust gases are often controlled with an in-vessel detector that automatically closes the exhaust valve or controls the addition of an antifoaming agent if there is a risk of the broth splashing or foaming the outlet. Each fermenter exhaust may be backed-up by a downstream cyclone. Thermal oxidation may also be applied where appropriate. Stack gas scrubbing, with hypochlorite or by using carbon adsorption or biological filters may be necessary for fermenter emissions that are malodorous. [EC 2006c]

If the biomass is classified as hazardous, it must be inactivated. This is carried out, for example, by treatment with heat, with chemicals or by application of vacuum evaporators at temperatures of 85 to 90 °C. Alternatively, the hazardous biomass is incinerated with sufficient heat (typically above 1100 ºC) and dwell times in order to achieve acceptable destruction efficiency.

Waste water streams from biological processing (including filtered broth) normally show high degradability of the organic load and are usually treated in a biological WWTP. The critical parameter is often the high nitrogen load, which represents a major challenge for a central biological WWTP. Hence, strategies, such as decentralised anaerobic treatment and removal of compounds containing nitrogen, may be applied. [EC 2006c] For




example, nanofiltration may be used as a pre-treatment step to remove nitrogen and organic nutrients from the effluent before biological waste water treatment [Ympäristökeskus 2004].

In general, many of the BAT conclusions of the OFC BREF are applicable to biological processes and techniques for prevention and reduction of environmental impacts are not considered to entail excessive costs for this sector.

e. Current interpretation(s) and other legislation

Many MS consider that bioethanol production (fermentation) is (or should be) covered by the point 4.1 (b) of Annex I (see Section 2.2). Currently, bioethanol production is perhaps the most common biological process used in the chemical industry. Regarding the number of bioethanol production installations, see section 3.1(e).

Furthermore, for example in UK, biochemical (i.e. biological) processes are treated as chemical processes. [Vincent, R.] In Walloon region in Belgium, these installations are covered by permits regardless of the IPPC. [Amand, M.] In Finland, enzyme production installations are covered by IPPC permits.

The IPPC chemical guidance, issued by the Commission explains that:“Chemical processing” implies that transformation by one or several chemical reactions takes place during the production process. An activity involving only physical processing (for instance simple blending or mixing of substances which do not chemically react…) would not be covered.

Thus the guidance makes clear difference between “chemical” and “physical” processing, but does not explicitly explain the position of “biological” processes. According to this guidance, the decision criterion seems to be whether or not chemical reactions take place. Biological processing is essentially chemical reactions driven by biological agents (thus also called biochemical processing). The Commission, in agreement with the MS, decided to address the specific issue of interpretation of the inclusion of biological processes in the context of the review of the IPPC Directive.

According to [Horváth, B.], there is a contradiction between the present draft EIA guidance and the draft IPPC guidance; the EIA considers biochemical procedures as chemical, while the IPPC guidance does not. However, the relevant EIA guidance was not identified3.

The FAQ 8 issued by the Commission [EC 2004a], provides guidance on the coverage of enzymes by the IPPC Directive:

Are enzymes covered by Annex I section 4?Many plant health products and pharmaceutical products are enzymes, and these are covered by sections 4.4 and 4.5 respectively. Beyond this, there does not appear to be any sound argument for their general inclusion. In particular, the link between enzyme production and food production (section 6.4) is tenuous, since even though enzymes may be used in such activities they are not themselves food products.

3 Published guidance on EIA in general is available at http://ec.europa.eu/environment/eia/eia-support.htm




However, the UNECE4 Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (also called the Aarhus Convention)5 associates enzyme production with chemical industry. The Annex I of the Convention includes an additional sub-paragraph under chemical industry section:4 (g) Chemical installations in which chemical or biological processing is used for the production of protein feed additives, ferments6 and other protein substances.

Cefic7 is not opposed to the inclusion of biological processes together with chemical processes in the scope of IPPC Directive, which is clearly said in the OFC BREF scope. In some cases it would provide a level playing field for ensuring minimum environmental impacts (and maximum energy efficiencies) for the potential supply of these chemicals. [Cefic 2007]

It has not been possible to estimate the number of biological processing installations (other than bioethanol) that are currently not covered by the scope of IPPC due to national interpretation. However, the number is assumed to be very limited, as currently biological processes are largely applies as part of large industries, as explained in part (b) above, and there are still only few independent installations.

Summary of key elements about the current practice regarding biological processing useful for this exercise:Biological processing in the production of chemicals refers to processes that use living micro-organisms or their purified enzymes as biocatalysts to bring about chemical reactions. Fermentation is a key process and used for example in the production of ethanol and bio-based polymers.At present, biological processing is commonly used in the fine chemicals sector, but it is increasingly used also in the large volume segments such as polymers, bulk chemicals and biofuels, and many other industrial sectors. Recent reports predict greater annual growth rates for fermentation products than for chemical production in general in the coming years.Environmental impacts from biological processing can be important; especially effluents with high COD and nutrient load are typically generated in these processes.OFC BREF describes BATs that are applicable to biological processes; such techniques for prevention and reduction of environmental impacts are not considered to entail excessive costs for this sector.Currently, biological processes are often carried out in large installations among other chemical processes. Hence they are generally covered by the IPPC permits already, either through a directly associated activity to an activity covered by Annex I or, depending the interpretation of Member States, as an Annex I activity. Even independent installations seem to be included under the IPPC permitting in many MS. Cefic supports such an interpretation.

2.2. Options regarding biological processes

4 Unites Nations Economic Commission for Europe5 http://www.unece.org/env/pp/documents/cep43e.pdf6 ‘Ferment’ is an agent (yeast, bacterium, mold or enzyme) that causes

fermentation7 European Chemical Industry Council




Option 1: Business as usual i.e. non-actionPros:

No additional legislative requirements in MS. Cons:

Does not solve the unclear situation as regards the scope of the IPPC Directive on this issue

Possible inconsistency of approaches between MS/regions, potentially leading to adverse impacts on the level playing field among producers across MS.

Depending the interpretation of the MS, exclusion of processes, such as fermentation, which are increasingly used to replace conventional chemical processes from the scope of the IPPC.

Remain unclear whether bioethanol would be covered under the IPPC Directive (see also Section 3.2)

Option 2: No change in Annex I, but modification of the chemicals guidance provided by the Commission on “chemical processing” to clarify that it covers also biochemical/‘biological processes. For example, as"Chemical processing" implies that transformation by one or several chemical reactions takes place during the production process, including reactions induced by biological agents OR (alternative wording) including biochemical reactions. Pros:

No additional legislative requirements at the Commission level. Cons:

Based on current wording of the Directive, difficult for the Commission to develop some guidance

Need to amend the national legislation in some MS Additional legislative requirements in some MS. The confusion is still likely to arise, as biological processes are explicitly

mentioned in §4.5 and not elsewhere. The remaining degree of flexibility provided by a guidance-based approach could

still allow different interpretations in MS.

Option 3: Explicit inclusion of biological processing in category 4 of the IPPC Directive. For example, asProduction within the meaning of the categories of activities contained in this section means the production on an industrial scale by chemical or biological processing of substances or groups of substances listed…OR (alternative wording) by chemical processing (including on biological processing) OR (including biochemical processing) of substances…Pros:

Harmonisation of the approaches between MS/regions, leading to level playing field among European producers (most MS already include these installations under the scope of the IPPC Directive).

Reflects the current practice where biological processes already play an important role in certain chemical sectors

Ensures a high level of environmental protection vis-à-vis a growing number of biological processes through BAT implementation.




Biochemical processing is made comparable to the traditional chemical processing and can be more easily considered as BAT, for example.

Cons: Need to amend the national legislation Additional legislative requirements in MS.

2.3. Analysis of options regarding biological processes

A qualitative approach is adopted for the analysis of the options proposed in section 2.2. For each of the issue, the relative advantages and disadvantages of the options are evaluated. The impact assessment matrix shown below summarise the results of the analysis and the thought process behind the ratings is explained in the following sub-sections.

In each cell a qualitative score of Y/N or ‘+’, ‘0’ or ‘-‘ has been given. A ‘+’ signifies beneficial impact with respect to the criterion in question; ‘-‘ a negative impact; and ‘0’ no impact. Increased magnitude of the impacts will be indicated using the notation ++ or --. In some cases, when there are other external influencing factors, a range is used, for example 0 to – or even + to -.

Option 1: No Action

Option 2: Update

guidance

Option 3: Change

Annex I to include

biological processing

General IssuesAddressing the problem – i.e. clarifying the position of biological processing in Article 4 of Annex I

0 + +++

Legislative changes 0 (-) -Environmental IssueLevel of environmental protection 0 + ++Economic IssuesImpact on firms: cost 0 0 to - 0 to -Impact on firms: competitiveness - / + - / + - / +Impact on public authorities (budget; resources)

0 0 to - 0 to -

Social IssuesConfidence of public on environmental control and pollution

0 + ++

Number of jobs – public authorities 0 0 0Number of jobs – in sector affected 0 0 0Other issues: Practicability and EnforceabilityPracticability: is it practical to implement?

0 + ++

Clarity and consistency (e.g. with other national and EU legislation)?

-- + ++

Is it enforceable? n/a + ++‘+++’: very beneficial effect; ‘++’: substantial beneficial effect; ‘+’: slight beneficial




effect; ‘0’ no effect; ‘-‘: negative effect, ‘--‘: substantial negative effect; ‘---‘: very negative effect; N/A: Not applicable; Y/N: yes/no

General issues

The issues of biological processing and bioethanol (see also 4.2) are very much interlinked, as alcohol fermentation is currently the most important biological process applied to the production of chemicals. Majority of the MS for which information was available consider that bioethanol is (or at least should be) in the scope of IPPC. Thus option 1 (no action) would, at the legislative level, leave unclear an issue that most stakeholders agree upon.

Option 2 could somewhat clarify the issue, but could still give room for debates over the issue. It would require no legislative change at the EU level, but potentially changes would be necessary in at least some MS.Bringing biological processing explicitly within the scope of the IPPC Directive (option 3) would greatly clarify the issue. It would require a legislative change at EU level and in some MS.

Environmental issues:

Options 2 and 3 may not have large environmental impacts in the short term, as in many MS the separate production installations (e.g. for bioethanol) are already covered by IPPC or other similar permits, and many other biological processes are currently carried out in large chemical plants, which are already permitted under the IPPC Directive.

However, biological processes in chemical industry are foreseen to grow substantially in the coming years. Thus, option 1 would miss the opportunity to apply BAT based permitting to diversifying production processes, growing production volumes and an increasing number of independent installations for biological processing. On the other hand, options 2 and 3 would allow the full benefits of the BAT based approach to be realised, as the sector is still at its early phase of development and many new installations will be built in the coming years.

Biological processes are in general considered to have environmental benefits in comparison to the classical chemical methods, but they are nevertheless not emission free. Biological processes are often associated with multimedia environmental impacts (air emissions from heat production, waste waters with high load of nutrients etc.) and thus the IPPC approach is justified. In principle, options 2 and 3 are both beneficial, regarding the level of environmental protection. Their impacts may be rather similar, but due to the more binding nature of option 3, it is judged to bring more benefits.

Furthermore, in case where both biochemical and chemical processes exist for a given product, the inclusion of both processes side by side under IPPC (options 2 and 3) could eventually promote the process which has overall the best environmental performance. The regulator could require a process move to BAT if there is a clear environmental benefit and if the processes use identical raw materials and produce end-products of the same quality. Such promotion could favour innovation in the field of alternative




biological process developments. This promotion is not possible if they are covered under different legislative frameworks.

Economic issues:

Many MS already permit relevant installations as if they were in the scope of IPPC. Hence, the costs of option 2 and 3 are not considered to be excessive, neither to companies nor to the authorities. Furthermore, cost effective BAT applicable to biological processing are provided in the OFC BREF. Such BAT conclusions were considered economically viable for the sector concerned by the experts of MS and industry.

Regarding competitiveness, two “levels” of competitiveness should be distinguished: competitiveness of biological processing with other chemical processing and the competitiveness between companies (with biological processing). Regarding the earlier, it has been argued that bringing biological processing within the scope, would remove one of the advantages of such processes vis-à-vis the classical chemical processing and bring more level playing field in this sector. As many MS already extend the IPPC to such installations, options 2 and 3 would harmonise the situation between the MS and thus enhance fair competition.

Social issues:

The considered options are not foreseen to have a significant effect neither on the number nor on the quality of jobs. All options occur at the level of authorities and/or companies, thus they do not directly affect the confidence of public on environmental control and pollution. However, the public is likely to appreciate that the increasing number of novel production methods, which are marketed as environmentally beneficial, are indeed controlled as any other chemical installation.

Other issues:

Both options 2 and 3 will not be difficult to bring into practice. Rather, they will support the current interpretation in many MS. Furthermore, permitting installations based on the substance produced (as provided in §4, Annex I) and not on the basis of production methods, can be considered more practical. In general, an amendment to the Directive (option 3) is more difficult to implement than the writing of guidance documents (option 2). At the same time it will provide a more solid basis for the decisions of permit authorities and thus will have more benefits from the enforcement point of view. Options 2 and 3, both should lead to more clarity and consistency in the interpretation of the Directive. Option 3 would bring the IPPC Directive more in line with the Aarhus Convention, which already includes production of enzymes (by chemical and biological processes) within the chemical industry. Bringing biological processes within the scope of the IPPC under §4 would increase the coherence of the permitting approach since a big part of these activities are already indirectly permitted as they are carried side by side with conventional chemical processes at many installations. The term ‘biochemical process’, which is more commonly used than the word ‘biological’ in the context of chemicals, reflects the fact that these processes involve, in essence, chemical reactions catalysed by biocatalysts.




3. Biofuels

3.1. Current practice regarding biofuels


‘Biofuels’ involve two types of products: biodiesel and bioethanol (Figure 2).

Figure 2 – Production chains of biodiesel and bioethanol [IFP]

Canola seed oilSunflower oil

Transesterification Vegetable oil esters or biodiesel Mixing

with diesel oil

Mixing with gasoline

BeetSugar cane

Wheat, corn,potato Starch

SugarsFermentation

Ethanol

Biodiesel

Biodiesel that is currently produced in Europe is a mixture of fatty acid alkyl esters produced by a chemical process of transesterification from vegetable oils such as rape seed oil, sunflower seed oil, soybean oil, and also from used frying oils (UFO) or animal fats. Fatty acid methyl ester (FAME) is currently the principal biodiesel. In the transport sector, it may be effectively used both when blended with fossil diesel fuel and in pure form.

Pure biodiesel can be used as a vehicle fuel in modified engines. Methyl esters blended in diesel oil (5% for private cars and 30% for captive fleets) can be used in all car engines. Tests undertaken by motor manufacturers in the European Union on blends with diesel oil up to 5-10%, or at 25-30% and 100% pure have resulted in guarantees for each type of use. [DOE 2006; EBB; EC 2004b]




Figure 3 – Biodiesel production process diagram [DOE 2006]

Although FAME is the principle (first generation) biodiesel at the moment, biodiesel is not limited to this. Biodiesel is not a single chemical species but it refers to substances with characteristics that enable them to fuel a compression ignition engine in a place of conventional diesel. Even the FAME biodiesel is in fact a mixture of methyl esters rather than a single pure ester. The specification of the fuel will depend on the feedstock and on the production method employed. The common international standard EN 14214 specifies the parameters that have to be met by biodiesel (Annex A).

New advanced technologies are being developed for the biodiesel production. “Second-generation” biodiesel is based on hydrogenating vegetable oils and animal fat from a variety of sources. In the process, fatty acids derived from the feedstock are converted chemically into an isoparaffin hydrocarbon. Water is first used to remove impurities, and then the fatty acids are converted into isoparaffin with the help of hydrogenation and oxygen content eliminated using water extraction. The paraffin hydrocarbon resulting from the hydrogenation process is essentially a synthetic diesel fuel. It can be blended directly with conventional diesel fuel or sold as such for onward refining. Neste Oil’s synthetic NExBTL biodiesel will be the world’s first second-generation biodiesel to be launched commercially; the new production plant in Finland is due to start up in summer 2007. [Neste, Neste 2006]

Work is also under way on gasifying biomass to process a third-generation biodiesel (so-called biomass to liquid, or BTL processing). In such a process syngas produced in gasification is subjected to Fischer-Tropsch synthesis (synthesis of long-chain hydrocarbons from CO and H2) to produce for example biodiesel. Both second and third generation biodiesel are in essence biobased hydrocarbons, i.e. basic organic chemicals.

Bioethanol

‘Bioethanol’ (or ‘fuel ethanol’) is the term used for agricultural ethyl alcohol or ethanol (CH3-CH2-OH) when it is used in the biofuel sector. Bioethanol and agricultural ethanol in general are made by fermenting the sugar components of biomass followed by




distillation (Figure 4). Currently in the European Union, it is made mostly from sugar beet and starch crops (cereals and potatoes).

Figure 4 – Bioethanol production process diagram [DOE 2006]

Bioethanol is no different from agricultural ethanol used for other applications than fuel (i.e. for beverages or industrial purposes). Most of the installations produce ethanol for the different end applications according to the market situation, rather than being specialised only to fuel ethanol for example. So ethanol becomes ‘bioethanol’ when it is sold for that purpose.

Chemically biologically produced ethanol is similar to the chemically produced ethanol and could thus be considered “basic organic chemical” [Cefic 2007].

Ethanol can be used as a fuel for cars in its pure form, but it is usually used either as an isobutylene derivative (ETBE) as a gasoline additive (up to 15% in petrol) or as a 5 % blend in petrol – up to 85% in flexible fuel vehicles. [DOE 2006; EC 2004b]

The possible ETBE derivation step is clearly a chemical process, in which ethanol (approximately 47%) reacts with petrochemical based isobutylene, and thus it will not be discussed further in this fact sheet.

As for biodiesel, advanced BTL technologies are being developed to allow cellulose biomass, like trees and grasses, to be used as feedstock for ethanol production.


Biodiesel

Biodiesel has been produced on an industrial scale in the European Union since 1992, largely in response to positive signals from the EU institutions. Today, there are approximately 120 plants in the EU producing up to 6.1 million tonnes of biodiesel annually. These plants are mainly located in Germany, Italy, Austria, France and Sweden. [EBB] However, there are production plants in most of the Member States (Annex B).

Compared to the previous year, the biodiesel production in 2005 increased by 65%, and was 3.18 million tonnes (Annex B). Further significant increase in production was expected for 2006 as the production capacity was estimated to increase by 43%. Further installations are underway or planned in many Member States, among others in Finland




and Sweden [Neste 2006; Undén 2006]. The number of plants in planning or building state is estimated at 30-50 by an EBB technical expert.

Until recently, most of the production units used to be small (5000 – 10000 tonnes/year) with some up to 100000 tonnes/year. However, this has been changing since a couple of years and new plants normally have annual capacities of 100000 – 300000 tonnes. Most biodiesel production takes place in agrochemical plants – some are dedicated to biodiesel productions while others produce other products as well (e.g. fertilisers). It is likely that in the future, more and more plants will be part of petrochemical refineries. [Amatruda, L.]

The Energy and Climate package adopted by the European Commission in January 2007 and endorsed by the European Council in March 2007 will have an important impact on the growth of biofuel market8. A renewable energy roadmap9 sets a binding 10% target for the share of biofuels in petrol and diesel in each Member State in 2020, to be accompanied by the introduction of a sustainability scheme for biofuels.

Biodiesel is expected to play an important role in meeting the target. Figure 5 illustrates the current medium-term projections for global biodiesel production. By 2010, the global biodiesel production is estimated to be three times the estimated in 2005, growth in European production being especially important. Probably the vast majority, if not all, of this new production will employ first generation technology, and agricultural crops will continue to account for the bulk of feedstock used by the sector. Second generation technologies (NExBTL biodiesel, for example) start entering into commercial production, third generation BTL biodiesel is expected to enter mainstream commercial production only after 2010. [EuropaBio 2006; Rabobank 2006]

Figure 5 – Global biodiesel production, 1995-2010 [Rabobank 2006]

Bioethanol

It is important to highlight that bioethanol production is intimately linked with the production of fermentation (or agricultural) ethanol in general. 80% of the European ethanol is produced by fermentation. The remaining 20% is produced synthetically (by purely chemical processing) in three installations.

Bioethanol (i.e. fermentation ethanol to be used as biofuel) is currently produced in most of the Member States. The EU-25 bioethanol production in 2005 was 726000 tonnes;

8 See http://ec.europa.eu/energy/energy_policy/documents_en.htm9 COM (2006) 848




produced in 27 installations (Annex C). This represented an increase of 74%, compared to the previous year [Ebio 2006b]. Yet, this is only 43% of the installed capacity (Annex C). Major progress is expected in 2007, when a number of new plants will start production and the effects of mandatory use of biofuels in a number of Member States will become visible [Ebio 2006a].

The bioethanol production is seeing strong growth and new installations that are already under construction (16 new installations and extension of 6 existing plants) will more than double the installed capacity by mid-2008, when the installed capacity is expected to reach 5000 million litres – roughly 4000 ktonnes (Annex D).

In addition to the installations that are already under construction, there are many plans for further additional units in different Member States, e.g. Finland, Slovak Republic and Sweden [Bezuch 2006; SBe; Undén 2006].

The new European energy policy10 which sets a binding 10% target for the share of biofuels in petrol and diesel in each Member State in 2020 will have an important impact on the growth of bioethanol market as well.

Figure 6 illustrates the current medium-term projections for global ethanol production. By 2010, the global fuel ethanol production in 2010 is expected to be close to double the output in 2005. However, the growth in EU is expected to be modest compared to USA and Brazil. As for biodiesel, most, if not all, of this new production will employ first generation technology, while second generation technologies (cellulosic ethanol, for example) will probably enter mainstream commercial production only after 2010. [EuropaBio 2006; Rabobank 2006]

Figure 6 – Global bioethanol production, 1995-2010 [Rabobank 2006]

Up to the present a lot of the bioethanol has been produced in the “generalist” ethanol installations that simply produce ethanol for all purposes. However, the new installations are usually dedicated to bioethanol production. The photos of these installations clearly show that they are large industrial installations rather than small artisan activity 11.


10 See http://ec.europa.eu/energy/energy_policy/documents_en.htm11 Unfortunately, it has not been possible to include such photos here for

copyright reasons.




No specific, quantified data was available on the environmental impacts of biodiesel and bioethanol production. Many studies have compared the environmental impacts of the biofuels to those of the conventional fuels. However, they usually provide an overall estimate over the life cycle of the fuels, but they do not specify nor quantify the impacts of the esterification/fermentation process itself.

Regarding contemporary biodiesel production, the environmental impacts are assumed to be similar to the esterification processes in the manufacture of other (large volume) organic chemicals. The BREF on Large volume organic chemicals [EC 2003] gives a general overview of the environmental issues of esterification processes:

More specifically, “production of biodiesel includes the handling and use of an alcohol (usually methanol) and a strong base (usually sodium hydroxide or potassium hydroxide, also known as lye). Environmental concerns that must be addressed include fugitive emissions of methanol, the ultimate disposal of the by-product glycerine, and the generation and disposal of wastewater containing free fatty acids that have a high biochemical oxygen demand (BOD).” [NH-DES 2006]

Bioethanol production is associated with environmental issues, such as: Dust (e.g. from grinding of raw materials such as cereals) CO2 and VOC emissions from fermentation processes Odour (due to VOC) Direct air emissions from on-site heat production (process heat) By-products/Waste from raw materials (e.g. starch and other grain fractions) and

from distillation (e.g. aldehydes and methanol) Use of chemicals such as hydrogen peroxide, phosphoric acid, sodium hydroxide,

copper sulphate and nitric acid, as well as divers chemical products for cleaning and disinfection of surfaces and process equipment

Water consumption Waste waters with elevated BOD/COD, nitrogen, phosphorus and suspended

solids content [Ympäristökeskus 2007].


The techniques for prevention or reduction of environmental impacts applicable to biodiesel and bioethanol production are elaborated in OFC and LVOC BREFs [EC 2003; EC 2006c].

For example, BAT is to assess the options and to optimise the energy consumption (for example, by using energetically coupled distillation). Regarding effluents, BAT is to treat effluents containing a relevant organic load, such as waste water streams from production




processes, rinsing and cleaning water, in a biological WWTP. BAT is to take full advantage of the biological degradation potential of the total effluent and to achieve BOD elimination rates above 99 % and yearly average BOD emission levels of 1 – 18 mg/l. The levels relate to the effluent after biological treatment without dilution. [EC 2006c]

e. Current interpretation(s) by MS and other legislation

Some MS consider biofuels to be out of the scope of the IPPC, as they consider that biofuels are not ‘basic chemicals’. In the context of the question “Can biofuel production be considered production of basic organic chemicals?”, it is important to distinguish the production of the biodiesel/bioethanol itself from the common step where these are mixed with normal diesel oil/gasoline to achieve the final fuel product. While the first step can be considered ‘production of basic organic chemical’ according to the chemical guidance issued by the European Commission, the latter step is rather a mixing operation. Such purely physical processes are excluded from the scope of the IPPC as clarified in the guidance.

The interpretation of biofuels as ‘basic’ chemicals is supported by the central position they occupy in a number of recent communications and directives of the Commission. The Biofuels Directive12 sets “reference values” of a 2% market share for biofuels in 2005 and a 5.75% share in 2010. An EU Strategy for Biofuels [EC 2006a] aims further to promote biofuels and prepare for their large-scale use. Renewable Energy Road Map [EC 2007b] considers biofuels as the only available large scale substitute for petrol and diesel in transport. The biofuels Energy Technology Plan considers that up to one quarter of EU road transport fuel needs can be met by clean and CO2 efficient biofuels by 2030 [EC 2007a].

Interpretations regarding biodiesel

Regarding the interpretation and national transposition, information has been available from 17 MS (both EU-15 and New Member States). The majority of them considers biodiesel to be covered by the point 4.1 (b) of Annex 1 as an ester13. Looking at the production volumes, at least 75% of the EU-27 capacity is known to be covered by IPPC permits already (see Figure 7) based on the data in Annex B and Annex E. The 14% of “(Yes)” in Figure 7 refer to the production in Italy, where most of the current production is carried out in oil refineries. Thus, the main production plants are subject to IPPC directive as an associated activity. However, dedicated biodiesel installations, which are the trend in the future, are considered to be outside the IPPC scope.

Figure 7 – The share of the EU-27 biodiesel production capacity (2006) already covered by IPPC or similar permits

12 Directive 2003/30/EC of 8 May 2003 on the promotion of the use of biofuels or other renewable fuels for transport (OJ L 123, 17.5.2003).

13 This reflects the fact that the conventional biodiesel is a product of transesterification. Biodiesel produced by new second- or third-generation technologies is composed of hydrocarbons, i.e. they would rather fall under 4.1 (b).




?9%

Yes75%

(Yes)14%

No2%

The share of ‘unknown’ corresponds to capacity in CY, DK, EL, LT, PL and SP. At least one MS (PT) considers biodiesel to be excluded, because it does not consider it as “basic chemical". Such an opinion may reflect confusion between the biodiesel (as a pure ester/hydrocarbon) and the final mixture of biodiesel and petrochemical diesel sold at gas station.

Chemically conventional biodiesel is a ester (or mixture of esters) and as such can be covered by §4.1 (b); new generations of biodiesel are hydrocarbons and thus they can be covered by §4.1 (a). Cefic highlights that biodiesel is an esterification product and a substance obtained by a chemical process. [Cefic 2007]

Interpretations regarding bioethanol

Most of the MS on which information has been available, and in which there is bioethanol production, consider the production installations to be in the scope of the IPPC directive under article 4.1 (b). Some countries admit that, according to the current wording of the Annex I, bioethanol may be out of Annex I, but it is nevertheless covered by the national permitting procedures. Figure 8 illustrates the situation based on data in Annex D and Annex F.

Figure 8 – The share of the EU-27 bioethanol production capacity (foreseen 2008) already covered by IPPC or similar permits

No10%

Yes83%

?7%

The 10% of “no” corresponds to production capacity in CZ, HU and PT. CZ and HU consider bioethanol to be out of the scope of IPPC as it is produced by biological process. PT considers bioethanol, similarly to biodiesel, to be excluded, because it does not consider it as “basic chemical". Such an opinion may reflect confusion between the bioethanol (as a pure ethanol) and the final mixture of bioethanol and petrochemical




gasoline sold at gas station. Production capacity in BG, EL, LT and PL covers most the unknown 7% in the above figure.

“This production process is a biotechnological process involving a chemical conversion. The production of bioethanol is carried out on an industrial scale in plants which can be regarded as chemical installations.” [Eberhartinger-Tafill]

Chemically bioethanol is similar to the chemically produced ethanol and as such can be covered by §4.1 (b).

Other legislation

Biofuels are flammable liquids and thus production installations above certain threshold have to comply with the requirements of the “Seveso directive” on the control of major-accident hazards involving dangerous substances14.

Summary of key elements about the current practice regarding biofuels useful for this exercise:‘Biofuels’ involve two distinct fuels: biodiesel and bioethanol. Biodiesel is a mixture of fatty acid alkyl esters produced by a transesterification (chemical process) from vegetable oils. ‘Bioethanol’ (or ‘fuel ethanol’) is the term used for fermentation ethanol when it is produced for/used in the biofuel sector. Bioethanol is made by fermenting (biological process) the sugar components of biomass followed by distillation.Currently, 6.1 million tonnes of biodiesel and 0.7 million tonnes of bioethanol are produced annually. Major progress is expected in 2007 and in the next few years, when the effects of mandatory use of biofuels in many MS will become visible. The average size of the installations is increasing and more and more dedicated sites are appearing. Environmental impacts from the production of biofuels should not be ignored. For example, effluents with high BOD/nutrient load are typically generated in these processes. It is also important to consider the best way to ultimately dispose of the by-products. OFC and LVOC BREFs describe BATs that are applicable to biofuel production processes; such techniques for prevention and reduction of environmental impacts are not considered to entail excessive costs.The majority of the MS from which information has been available with reasonable efforts already cover both biodiesel and bioethanol production by IPPC permits under §4.1(b).

3.2. Options regarding biofuels


14 Consolidated version of the Seveso II Directive (Council Directive 96/82/EC on the control of major-accident hazards involving dangerous substances), amended by 2003/105/EC.




No additional legislative requirements in MS; in many MS, installations are already covered by environmental permits.

Cons: Inconsistency of approaches between MS/regions, potentially leading to adverse

impacts on competitiveness among producers across MS. Potential exclusion from the scope of the IPPC processes which are to grow

significantly in number and volume in the future. Potential adverse impacts from biofuel production installations, especially in the

future with increasing and more “industrialised” production.

Option 2A: Inclusion of biofuels in Article 4, by bringing biological processing in the scope as described in Option 2 in Section 2.2. This assumes that biodiesel is currently already covered as a chemically produced ester. Pros:

Would allow covering bioethanol (and biodiesel) production by the IPPC. Would enable the environmental protection vis-à-vis a growing production

volumes of bioethanol (and biodiesel).Cons:

Need to amend the national legislation regarding biological processing The biofuels are not explicitly covered by the IPPC and thus they position is not

clarified. The debate on whether they should be considered ‘basic organic chemicals’ is likely to continue.

Option 2B: As 2A, but in addition guidance provided by the Commission to clarify that both biodiesel and bioethanol are to be considered ‘basic organic chemicals’.Pros:

Would allow covering bioethanol (and biodiesel) production by the IPPC. The position of biofuels would be clarified which is expected to lead to

harmonisation of permitting practices in MS. Would enable the environmental protection vis-à-vis a growing production

volumes of bioethanol and biodieselCons:

The remaining degree of flexibility provided by a guidance-based approach could still allow different interpretations in MS.

Need to amend the national legislation regarding biological processing.




Option 3: Bringing biological processing in the scope as described in Option 2 in Section 3.1, and addition of biofuels as a separate sub-category (e.g. 4.7) Pros:

Harmonisation of the approaches between MS/regions, leading to level playing field among European producers.

Ensures the environmental protection vis-à-vis an increasing production of biofuels.

Cons: Against the current interpretation of many MS, who consider biofuels fitting

under 4.1 (b) Chemically biodiesel and bioethanol fall under the existing 4.1 (b), so a separate

category could thus be considered useless. Using the term “biofuels” may add confusion, as the term is not reserved

exclusively to liquid fuels. Biomass/wood etc. can also be called biofuels. Thus inclusion of “biofuels”, could be taken to mean, for example, biological treatment of biomaterial (effectively composting) before it is used as a (co-) fuel.On the other hand, naming “bioethanol and biodiesel” may cause further confusion between activities of production of basic chemical constituents and the preparation of the final fuel mixes. Furthermore, new alternative substances may be developed, which would require Annex I to be updated, if the substances are separately named.

3.3. Analysis of options regarding biofuels

A qualitative approach is adopted for the analysis of the options proposed in section 3.2. See also the introduction to the section 2.3.

Option 1: No Action

Option 2A*:Change Annex I to include biological processing

Option 2B:As 2A, with additional guidance

Option 3:Change Annex I to include biofuels as an own category

General IssuesAddressing the problem15 – i.e. clarifying the position of biofuels in Article 4 of Annex I

0 0 to + ++ +++

Legislative changes 0 - - --Environmental IssueLevel of environmental protection 0 + ++ +++Economic IssuesImpact on firms: cost 0 0 to - 0 to - 0 to -Impact on firms: competitiveness 0 - / + - / + - / +Impact on public authorities (budget; resources)

0 0 to - 0 to - 0 to -

15 This question looks at whether the design of the option actually addresses the real problem – in the sense of focus rather than effectiveness. Effectiveness issues come after. Hence it is the intention and targeting of the option that is assessed here and not its effect.




Social IssuesConfidence of public on environmental control and pollution

0 + + +

Number of jobs – public authorities 0 0 0 0Number of jobs – in sector affected 0 0 0 0Other issues: Practicability and EnforceabilityPracticability: is it practical to implement?

n/a Y Y Y

Clarity and consistency (e.g. with other national and EU legislation)?

n/a + ++ -

Is it enforceable? n/a Y Y Y‘+++’: very beneficial effect; ‘++’: substantial beneficial effect; ‘+’: slight beneficial effect; ‘0’ no effect; ‘-‘: negative effect, ‘--‘: substantial negative effect; ‘---‘: very negative effect; N/A: Not applicable; Y/N: yes/no

* As Option 3 on Biological processing issue.

General issues

It should be remembered that ‘biofuels’ comprise two different substances: biodiesel and bioethanol. While most informants from MS and the industry consider biodiesel to already be in the scope of IPPC, bioethanol has been a problem due to the lack of clarity of the position of ‘biological processing’ in the current §4. (see section 4.1 above)

From the point of view of chemistry, both substances are covered by § 4.1(b) of Annex I (biodiesel as an ester and bioethanol an alcohol). However, the “biological” production method of bioethanol has created confusion as to whether or not it should be covered. Option 2A would create a basis on which bioethanol could clearly be considered being under the scope.

Few MS maintain that both substances are ‘biofuels’ and biofuels are not ‘basic organic chemicals’. Option 2A is not likely to clarify this issue, whereas option 2B should make it clearer. Yet, even option 2B may leave room to further debate on the issue due to its non-binding character.

Option 3 will be the clearest regarding biofuels. However, introducing the word “biofuel” into §4 may be problematic as outlined in chapter 3.2. On the other hand, restricting a new activity description to “production of biodiesel and bioethanol” is not without problems either.

Environmental issues:

No general quantified information was obtained on the environmental impacts of biodiesel/bioethanol plants. Exact impacts of the different options are also difficult to estimate as the options only concern part (a minority) of MS, who have so far left biodiesel/bioethanol out of the IPPC permit system. However, as explained in section 2.2, production of biofuels is associated with multimedia environmental impacts (air emissions from heat production, waste waters with high load of nutrients, wastes/by-products etc.) and thus the IPPC approach is justified.




Furthermore, the EU support on renewable fuels is going to lead to significant increase in the production quantities over the coming years. The new biofuel production installations that are currently being built are in general large, industrial installations and it is important to control their emissions. The fact that the sector is still at its early phase of development will allow the full benefits of the BAT based approach to be realised.

Economic issues:

The considered options are not foreseen to affect considerably neither the number nor the quality of jobs. The fact that these installations are already IPPC permitted in many MS, including new MS such as Romania, suggests that the cost of option 2 and 3 are economically viable for the sector.

European ethanol producers are facing a competition pressure from Brazilian and USA producers, and hence they may in principle be against stricter pollution control measures. However, such claims do not seem corroborative as the majority of European bioethanol production installations are already submitted to IPPC permitting at national level.

A fear has been expressed that if options 2 or 3 were implemented, even small wine producers that send their overproduction to be distilled to bioethanol could be brought within IPPC permitting as chemical installations – with negative economic consequences16. However, this is not the aim of these options and against the interest of the Commission. If needed, additional guidance could be produced to specify that installations whose main activity is beverage production are not to be considered as biofuel production installations.

Social issues:

The options under consideration are not expected to have a significant effect neither on the number nor on the quality of jobs. All options occur at the level of authorities and/or companies, thus they do not directly affect the confidence of public on environmental control and pollution. However, the public is likely to appreciate that the increasing number of biofuel production installations and their emissions are properly controlled.

Other issues:

Many of the existing bioethanol production installations actually produce fermented ethanol for beverage/industrial/bioethanol. In general, it may be difficult to classify such ethanol production installations to either chemical or food industry (whether to be covered under chemical industry or food and drink production) and it seems difficult to solve this issue in Annex I. However, this issue may be taken into account, for example,

16 Distillation of wine to (bio)ethanol is taking place under the Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine (see http://europa.eu/scadplus/leg/en/lvb/l60031.htm). The regulation provides a number of provisions for distillation. Distillation scheme applies for example to wine produced in excess of the normal quantity. In addition, a voluntary crisis-distillation measure may be implemented if there is an exceptional case of market disturbance caused by serious surpluses or quality problems. In 2006, up to 510 million litres of surplus wine were to be made into bioethanol that could only be used as biofuel or industrial alcohol. (http://www.edie.net/news/news_story.asp?id=11558&channel=0) Such distillation takes place in large distilleries rather than on wine production sites.


http://www.edie.net/news/news_story.asp?id=11558&channel=0

http://europa.eu/scadplus/leg/en/lvb/l60031.htm



in the revision of relevant BREFs, where it can be made sure that similar fermentation processes in beverage and biofuel production have similar BAT. The benefit of the options 2 and 3 is that they give the basis to extend the IPPC to an increasing number of new, big dedicated bioethanol installations, which clearly are not aimed at food and beverage production.

4. Pharmaceutical intermediates

4.1. Current practice regarding pharmaceutical intermediates


Intermediates are the primary chemicals used for the manufacture of products such as Active Pharmaceutical Ingredients (APIs). The intermediates are prepared on an industrial scale from basic organic raw materials (usually aromatic) by various chemical procedures (unit processes). Often, the route taken to go from the basic organic raw material to the target product is via several unit processes and possibly includes several unit operations (see Annex G), which are common to the industrial organic chemistry. [EC 2006c]

The manufacture of intermediates is an important part of industrial organic chemistry. Typical starting raw materials are aromatic hydrocarbons, such as benzene, toluene, naphthalene, anthracene, pyrene, phenol, pyridine and carbazol, as well as a wide range of aliphatic compounds like, e.g. alcohols and carbonic acids. In principle, two types of intermediates can be distinguished:

“Primary intermediates” are substances that are common to different sub-sectors of the chemical industry (e.g. benzene, toluene, naphthalene, anthracene, phenol, as well as a wide range of aliphatic compounds like, e.g. alcohols, carbonic acids, heterocyclic compounds).

“Secondary intermediates” are specific to a sub-section; in the case of pharmaceutical sector these are called pharmaceutical intermediates (PhIs). [EC 2006c]. Examples of an vast variety of PhIs include, pyrazolone, N-[4-(3,4-dichlorophenyl)-3,4-dihydro-1(2H)naphthalenylidene]methanamine).


Primary intermediates are likely to be manufactured by chemical installations for the production of basic organic chemicals. The pharmaceutical intermediates are often produced within API production plants for internal production and/or to be sold [EC 2006c]. There may be few installations that are specialised in PhIs with no API production, but such installations are likely to produce only small quantities of special intermediates.

There are roughly 330 pharmaceutical installations in those MS where data has been available and the total number is expected to be higher. Only one MS has stated that it does not have any such installations. (see Annex H) However, nobody has been able to estimate how many of these produce exclusively/mainly pharmaceutical intermediates. It is hard to get precise figures on the size and structure of pharmaceutical intermediates, as they are often internally used. On the other hand, it is not always easy to draw a line between general and pharmaceutical intermediates. Furthermore, pharmaceutical industry




is one of the most secretive sub-sectors of chemical industry and data on production sites and capacities is not readily available.


No information has been available on the specific environmental impacts of PhI production. However, it is reasonable to assume that the impacts are similar to corresponding unit processes in the manufacture of active pharmaceutical ingredients and other (fine) organic chemicals which are already covered by the IPPC.


The techniques for prevention or reduction of environmental impacts applicable to manufacture of PhI are elaborated in OFC BREF [EC 2006c], which provides BAT for prevention and reduction of environmental impacts. See also sections 2.1(d) and 3.1(d).

e. Current interpretation(s) by MS and other legislation

Annex I, §4.5 covers explicitly the “production of basic pharmaceutical chemicals”. Some MS consider pharmaceutical intermediates also to be covered by the activity 4.5. However, many MS exclude them from 4.5, but a plant producing intermediates is generally considered to fall under another activity descriptions: either 4.1 or 4.2. (see Annex I) According to the author of the OFC BREF, there may be few installations that produce pharmaceutical intermediates with no API production, but even such installations are already likely to be covered by the IPPC Directive in practice [Serr, B.].

According to Cefic, most of the MS do regulate PhIs under IPPC already. In their opinion, since PhIs cover a variety of organic or inorganic chemicals that may be used for other purposes as well, it does not really matter if these are covered under §4.5 or some other article. Cefic would like to ensure that all MS regulate this activity, but they do not believe that further guidance would add anything. Regarding the coverage by BREFs, PhIs are considered as OFC and treated accordingly. [Cefic 2007]

4.2. Options regarding pharmaceutical intermediates


No additional legislative requirements in MS; most of the installations are considered to be covered by IPPC permits already.

Cons: Inconsistency of approaches between MS/regions, potentially leading to adverse

impacts on competitiveness among producers across MS. Continuing confusion of the position of pharmaceutical intermediates within

IPPC.

Option 2: No change in Annex I, but guidance provided by the Commission on pharmaceutical intermediates, along the lines of:Pharmaceutical intermediates can be considered basic organic chemicals and their production in industrial scale is to be covered under category 4. Depending on the nature




of the intermediate, they may fall in different sub-categories (e.g. 4.1, 4.2 or 4.5).Pros:

No additional legislative requirements in MS; most of the production of pharmaceutical intermediates is already by IPPC permits already.

Corresponds to the common understanding and practice of the position of the pharmaceutical intermediates vis-à-vis Annex I.

Cons: The remaining degree of flexibility provided by a guidance-based approach could

still allow different interpretations in MS.

Option 3: Inclusion of pharmaceutical intermediates explicitly under category 4, for example in 4.5 (processes for the production of pharmaceutical intermediates and basic pharmaceutical products) or by dealing the term "basic".Pros:

Ensures that production of pharmaceutical intermediates and its environmental impacts are covered by the IPPC.

Cons: Inconsistency with the rest of the article 4. If pharmaceutical intermediates are

added, other chemical intermediates should perhaps be mentioned as well. Difficulty to draw a clear line between pharmaceutical and other chemical

intermediates. This could be solved by removing the term "basic" in category 4.1, 4.2 and 4.5.

4.3. Analysis of options regarding pharmaceutical intermediates

No impact assessment matrix is provided for this issue. Many MS wished this issue to be clarified, but no MS could provide a single example of an installation dedicated only to the production of pharmaceutical intermediates.

All the feedback suggests that significant installations for the production of pharmaceutical intermediates are very likely to be covered by the IPPC permits already, either under §4.5, 4.1 or 4.2 Furthermore, industry and some other stakeholders have pointed out that if pharmaceutical intermediates are explicitly brought in Annex I, other chemical intermediates should maybe be mentioned as well.

Yet, industry has also remarked that there are still open questions regarding pharmaceutical intermediates (PhI), on which guidance could be provided: what is a PhI? Is a mixture of ingredients considered as PhI? How to define the split between PhIs and health care products? When does an intermediate become a finished product (e.g. is a bulk product which goes into a tablet line still an intermediate or a finished product in a different form)?

The removal of the term “basic” in categories 4.1, 4.2 and 4.5, which is taken up in option 3 above, should be considered with care. It may introduce further interpretation problems related to the line between chemical product (e.g. plastic polymer, currently under the scope of Annex I) and final product (e.g. plastic object made of pure polymer, currently out of the scope of Annex I).

5. Summary




The current evaluation suggests that differences exist in the interpretation of Annex I regarding biological processing, biofuels and pharmaceutical intermediates and action is recommended to clarify and consequently harmonise the legislation at the EU level.

Although it has been unclear to the MS as to how the current wording of the Annex I should be interpreted, most MS (of which information was available) and industry seem to agree on the same interpretations, namely:- bringing the biological processes in the scope of article 4, which would also bring

bioethanol to the scope- biodiesel production is within the scope already- most of the production of pharmaceutical intermediates is already covered by the IPPC

permits under one or the other of the sections in §4

The environmental impacts of the relevant processes can be important and more importantly the impacts are similar to impacts from many other chemical processes that are already covered under the directive. Thus it would be coherent to consider biological processing as well as biofuels as part of §4 of Annex I.

6. Main references

[Cefic 2007] Cefic (2007) Cefic Comments to Study “Data gathering and impact assessment part II”, 17 February 2007,

[DOE 2006] U.S. Department of Energy (2006) “ABC’s of Biofuels”, http://www1.eere.energy.gov/biomass/abcs_biofuels.html#prod (viewed 11/01/2007)

[EBB] European Biodiesel Board, www.ebb-eu.org/ (viewed 26/12/2006)

[eBio 2006a] European Bioethanol Fuel Association (2006) “Record growth in bioethanol fuel production 2005” – press release 12 June, available at www.ebio.org/ (viewed 05/01/2007)

[eBio 2006b] European Bioethanol Fuel Association, www.ebio.org/ (viewed 14/01/2007)

[EC 2003] EC (2003) Reference Document on Best Available Techniques in the Large Volume Organic Chemical Industry, available at http://eippcb.jrc.es/pages/FActivities.htm

[EC 2004a] EC (2004) “Frequently asked questions concerning how to understand certain provisions of Council Directive 96/61/EC on integrated pollution prevention and control (IPPC)”, Brussels.

[EC 2004b] EC, DG ENTR (2004) “Promoting biofuels in Europe”, available at http://ec.europa.eu/energy/res/publications/doc/2004_brochure_biofuels_en.pdf (viewed 14/01/2007)


http://ec.europa.eu/energy/res/publications/doc/2004_brochure_biofuels_en.pdf

http://ec.europa.eu/energy/res/publications/doc/2004_brochure_biofuels_en.pdf

http://eippcb.jrc.es/pages/FActivities.htm

http://www.ebio.org/

http://www.ebio.org/

http://www.ebb-eu.org/

http://www1.eere.energy.gov/biomass/abcs_biofuels.html#prod



[EC 2005] EC, DG JRC (2005) “Techno-economic feasibility of large scale production of bio-based polymers in Europe”, available at ftp://ftp.jrc.es/pub/EURdoc/eur22103en.pdf (viewed 15/01/2007

[EC 2006a] EC (2006) Commission Communication – An EU Strategy for Biofuels, COM (2006) 34 final, available at http://ec.europa.eu/agriculture/biomass/biofuel/com2006_34_en.pdf (viewed 17/07/2007)

[EC 2006b] EC (2006) IPPC Permitting Data Summary, 05/05/2006, available at http://forum.europa.eu.int/Public/irc/env/ippc_rev/library?l=/implementation_entec&vm=detailed&sb=Title (viewed 02/05/2007)

[EC 2006c] EC (2006) Reference Document on Best Available Techniques for the Manufacture of Organic Fine Chemicals, available at http://eippcb.jrc.es/pages/FActivities.htm

[EC 2007a] EC (2007) Commission Communication – Towards a European Strategic Energy Technology Plan, COM(2006) 847 final, available at http://eur-lex.europa.eu/LexUriServ/site/en/com/2006/com2006_0847en01.pdf (viewed 17/07/2007)

[EC 2007b] EC (2007) Commission Communication – Renewable Energy Road Map - Renewable energies in the 21st century: building a more sustainable future, COM(2006) 848 final, available at http://ec.europa.eu/energy/energy_policy/doc/03_renewable_energy_roadmap_en.pdf (viewed 17/07/2007)

[IBAW 2005] IBAW (2005) “Highlights in Bioplastics“, available at http://www.european-bioplastics.org/media/files/docs/en-pub/050203_Highlights_in_Bioplastics_en.pdf (viewed 11/01/2007)

[IEG 2005a] IEG (2005a) Summary record of the 1st meeting of the IPPC Experts’ Group, Sub group on Interpretation of Annex 1 and “Installation”, London, 1 July 2005

[IEG 2005b] IEG (2005b) Draft summary record of the 2nd meeting of the IPPC Experts’ Group, Sub group on Interpretation of Annex 1 and “Installation”, Brussels, 12 October 2005

[IEG 2006] IPCC Expert Group (2006) Draft summary record of the 4th meeting of the IPPC Experts’ Group, Sub group on Interpretation of Annex 1 and “Installation”, Brussels, 26 April 2006.

[IPF] IFP, “Biofuels – the traditional technologies”, http://www.ifp.fr/IFP/en/ifp/ab13_02.htm (viewed 14/01/2007)

[NH-DES 2006] New Hampshire Department of Environmental Services (2006) Environmental Permitting, Regulations and Other Requirements Related to the Manufacture of Biodiesel, available at http://www.des.state.nh.us/factsheets/co/co-16.htm (viewed 22/04/2007)


http://www.des.state.nh.us/factsheets/co/co-16.htm

http://www.ifp.fr/IFP/en/ifp/ab13_02.htm

http://www.european-bioplastics.org/media/files/docs/en-pub/050203_Highlights_in_Bioplastics_en.pdf

http://www.european-bioplastics.org/media/files/docs/en-pub/050203_Highlights_in_Bioplastics_en.pdf

http://eippcb.jrc.es/pages/FActivities.htm

http://forum.europa.eu.int/Public/irc/env/ippc_rev/library?l=/implementation_entec&vm=detailed&sb=Title

http://forum.europa.eu.int/Public/irc/env/ippc_rev/library?l=/implementation_entec&vm=detailed&sb=Title

http://ec.europa.eu/agriculture/biomass/biofuel/com2006_34_en.pdf

ftp://ftp.jrc.es/pub/EURdoc/eur22103en.pdf



[Neste] Neste Oil, “Three generations of biodiesel production”, available at http://www.nesteoil.com/default.asp?path=1,41,540,2384,7906,7907,7909 (viewed 11/06/2007)

[Neste 2006] Neste Oil (2006) “Neste Oil to build a second biodiesel plant at Porvoo” – press release, available at http://www.nesteoil.com/default.asp?path=1;41;540;1259;1261;5043;7077 (viewed 11/06/2007)

[Novozymes] Novozymes, http://www.novozymes.com/en/MainStructure/AboutUs/Locations/Denmark+-+Kalundborg/ (viewed 11/01/2007)

[OECD 2001] OECD (2001) The Application of Biotechnology to Industrial Sustainability – a primer, available at http://www.oecd.org/dataoecd/61/13/1947629.pdf (viewed 19/02/2007)

[Rabobank 2006]Rabobank (2006) Financing and the emerging bio-energy markets, available at http://www.rabobankgroep.nl/download/Rabobank_bio-energy_totaal_DEF.pdf (viewed 19/02/2007)

[SBe] Suomen Bioetanoli Oy, www.sbe.fi (viewed 14/01/2007)

[UEPA 2006] UEPA (2006) 2005 Fuel ethanol production vs consumption, available at http://www.uepa.be/news.php (23/02/2007)

[Ympäristökeskus 2003]Keski-Suomen Ympäristökeskus (2003) Ympäristölupapäätös (Environmental permit) – Genencor International Oy, Jämsänkoski, Finland

[Ympäristökeskus 2004]Uudenmaan Ympäristökeskus (2004) Ympäristölupapäätös (Environmental permit) – Genencor International Oy, Hanko, Finland

[Ympäristökeskus 2007]Länsi-Suomen Ympäristökeskus (2007) Ympäristölupapäätös (Environmental permit) – Altia, Koskenkorva, Finland, available in Finnish at http://www.environment.fi/download.asp?contentid=62547&lan=fi (viewed 09/03/2007)


http://www.environment.fi/download.asp?contentid=62547&lan=fi

http://www.environment.fi/download.asp?contentid=62547&lan=fi

http://www.uepa.be/news.php

http://www.sbe.fi/

http://www.rabobankgroep.nl/download/Rabobank_bio-energy_totaal_DEF.pdf

http://www.rabobankgroep.nl/download/Rabobank_bio-energy_totaal_DEF.pdf

http://www.oecd.org/dataoecd/61/13/1947629.pdf

http://www.novozymes.com/en/MainStructure/AboutUs/Locations/Denmark+-+Kalundborg/

http://www.novozymes.com/en/MainStructure/AboutUs/Locations/Denmark+-+Kalundborg/

http://www.nesteoil.com/default.asp?path=1,41,540,2384,7906,7907,7909

http://www.nesteoil.com/default.asp?path=1,41,540,2384,7906,7907,7909



7. Contacts / Acknowledgements

We express our gratitude to the following persons who have provided information on the current practice and important data concerning this potential amendment and also useful comments on our approach of analysis.

Amand, M., Ministére Région wallonne – DG RNE, Belgium Amatruda, L., European Biodiesel Board Babcsany, I., National Inspectorate for Environment, Nature and Water; Hungary Bezuch B., Slovak Republic Cohors-Fresenborg, D., Federal Environmental Agency, Germany Danescu, R., Amochim, Romania Demetriou, M., Environmental Service, Ministry of Agriculture, Natural Resources

and Environment, Cyprus Eberhartinger-Tafill, S., Federal Ministry for Agriculture, Forestry, Environment

and Water Management, Austria Fratricova, M., Ministry of Environment, Slovak Republic Geimer, C., Adminstration de l’environnement, Luxembourg Horváth, B., Ministry for Environment and Water, Hungary Kapustova, B., IPPC Unit at the Environmental Agency, Slovak Republic Kramzaka, I., Environmental State Bureau, Latvia Maidre, T., Bemixe OY, Estonia Maršák, J., Ministry of the Environment, Czech Republic Mikulec, J., Research Institute Slovnaft VURUP on behalf the Slovak Industry

Assotiation Milillo, A., Ministry of the the Environment, Italy Nitschneiderová, H., IPPC Department at the Environment Inspectorate, Slovak

Republic Roos, P., Ministry of Housing, Spatial Planning and the Environment, The

Netherlands Serr, B., European IPPC Bureau, Sevilla Slavík, J., Ministry of the Environment, Czech Republic Undén, Å., Swedish Environmental Protection Agency, Implementation and

Enforcement Department, Industries Section, Sweden Vestergaard, V., Danish EPA, Industrial Division Vierhout, R., eBio Vincent, R., Department for Environment, Food and Rural Affairs, UK Werling, K., Lantmännen Agroetanol AB, Sweden Zerjav, J., Slovenia




Annex A: European Standard for Biodiesel EN 14214

Specification Limit(s) Unit Test methodMin. Max.

Ester content 96.5 - % (m/m) EN 14103Density at 15°C 860 900 kg/m3 EN ISO 3675,

EN ISO 12185Viscosity at 40°C 3.5 5.0 mm2/s EN ISO 3104,

ISO 3105Flash point 120 - °C EN ISO 3679Sulphur content - 10.0 mg/kg EN ISO 20846,

EN ISO 20884Carbon residue (on 10% distillation residue)

- 0.30 % (m/m) EN ISO 10370

Cetane number 51 - - EN ISO 5165Sulphated ash content - 0.02 % (m/m) ISO 3987Water content - 500 mg/kg EN ISO 12937Total contamination - 24 mg/kg EN 12662Copper strip corrosion (3h at 50°C)

1 - - EN ISO 2160

Oxidation stability, 110°C

6.0 - h EN 14112

Acid value - 0.50 mg KOH/g EN 14104Iodine value - 120 g iodine/100g EN 14111Linolic acid methyl ester

- 12 % (m/m) EN 14103

Fatty acid methyl esters (≥4 double bonds)

- 1 % (m/m) -

Methanol content - 0.20 % (m/m) EN 14110Monoglyceride content - 0.80 % (m/m) EN 14105Diglyceride content - 0.20 % (m/m) EN 14105Triglyceride content - 0.20 % (m/m) EN 14105Free glycerol - 0.02 % (m/m) EN 14105,

EN 14106Total glycerol - 0.25 % (m/m) EN 14105Alkaline metals (Na+K) - 5.0 mg/kg EN 14108,

EN 14109Alkaline earth metals (Ca+Mg)

- 5.0 mg/kg prEN 14538

Phosphorus content - 10.0 mg/kg EN 14107

Annex B: Biodiesel production in 2005 per Member State [EBB]

Member State 2005 production*

2006 production

Number of installations [questionnaire replies from




(ktonnes) capacity**(ktonnes)

Advisory Group]

Germany 1669 2681 *France 492 775 *Italy 396 857 *Czech Republic

133 203 *

Poland 100 150 *Austria 85 134 Around 5Slovakia 78 89 2Spain 73 224 *Denmark 71 81 *UK 51 445 *Slovenia 8 17 2Estonia 7 20 *Lithuania 7 10 *Latvia 5 8 1 operating;

3-4 plannedGreece 3 75 *Malta 2 3 *Belgium 1 85 1 (Wallonie)Cyprus 1 2 *Portugal 1 146 *Sweden 1 52 *Hungary n/a 12 *The Netherlands

Not known Not known 1 operating;4 in construction (capacity 126

mill. tonnes/year);several other planned

Finland, Ireland, Luxembourg

n/a 0 n/a

TOTAL 3184 6069* Production figures are subject to a +/- 5% margin of error.** Calculation based on 330 working days per year, per plant. The figures represent the EU-25 biodiesel capacity on July 1, 2006. As a comparison, the 2005 capacity was 4228000 tonnes. I.e. the production capacity >> actual production.

* no information provided

Annex C: Bioethanol production 2005 in EU-25 [Ebio 2006b]

Member Production (106 Production (ktonnes)




State litres)[eBio 2006b]

[eBio 2006b; UEPA 2006]

ES 303 240.0 - 241.2DE 165 120.0 - 131.3SE* 153 121.8 – 130.2FR 144 100.8 - 114.7PL 64 50.9 – 68.0HU 35 11.8 - 27.8FI 13 10.3 – 36.8Latvia 12 1.0 - 9.5Lithuania 8 6.3NL 8 6.3IT 8 6.3CZ - 1.1Total 913 716.0 - 726.2* About 90 million litres are based on wine alcohol imports




Annex D: Installed bioethanol production capacity in EU-25 [Ebio 2006b]

Member State Company – Installation

Production

capacity 2006

(106 litre)

Additional production capacity*

2008(106 litre)

Feedstock

AT Agrana n/a 240 Cereals

BEBiowanze SA – Wanze n/a 300 Cereals/sugar

beetAlcoBio Fuels – Gent n/a 100 CerealsAmylum – Aalst n/a 35 Cereals

BG Bulgaria

Euro Ethyl GmbH – Silistra 10 30 Cereals

CZ

Agroetanol TTD - Dobrovice 20 60 Sugar beet

PLP - Trmice n/a 100 CerealsEthanol Energy - Vrdy n/a 60 Cereals

DE

Verbio – Zörbig 100 CerealsVerbio – Schwedt 230 Cereals

KWST – Hannover 40 Cereals/wine alcohol

CropEnergies – Zeits 260 100a Cereals, a) sugar beet

SASOL – Herne 76 CerealsNordzucker AG – Klein-Wanzleben n/a 130 Sugar beet

Wabio Bioenergie – Bad Köstritz) n/a 8.4

ES

Ecocarburantes Españoles – Cartagena 150 Cereals/wine

alcohol

Bioetanol Galicia 176 Cereals/wine alcohol

Biocarburantes Casilla & Leon – Salamanca 195 5b

Cereals, b) straw cellulose

FI Altia – Koskenkorva n/a 76 CerealsFR Tereos – Artenay,

Morains, Origny Sainte-Benoîte

128 Sugar beet

Tereos – Lillebonne n/a 300 CerealsTereos – Origny Sainte- - 300 Cereals




BenoîteCristanol – Arcis sur Aube 150 Sugar beet

Cristanol/Deulep 40 Sugar beetCristanol I – Bezancourt n/a 150 CerealsSLS/Ryssen – Eppeville 50 Sugar beetSLS/Ryssen – Dunkerque n/a 100 Raw alcoholAB Bioenergy France – Lacq n/a 250 Cereals

Greece Helenic Sugar EBZ n/a 150 Sugar beet

HUHungrana – Szabadegyhaza 60 Cereals

Györ Distillery – Györ 16 CerealsIT Alcoplus – Ferrara 42 CerealsLatvia Jaunpagastas – Riga 12 CerealsLithuania Biofuture 31 CerealsNL Royal Nedalco 35 200 Cereals

PLAkwawit – Seszno 100 CerealsCargill Polska – Wroclaw 36 Cereals

RO Amochim 18 Cereals

SEAgroetanol – Norrköping 50 39 CerealsSEKAB 100 Wine alcohol

SI Enviral n/a 138 CerealsSK (Not known) 100 (Not known)a

UK British Sugar – Downham n/a 70 Sugar beetTOTAL 2125 2921* Additional installed production capacity by mid-2008 (all already under construction)a According to [Nitschneiderová, H.; Mikulec, J.]




Annex E: Member States’ interpretation regarding biodiesel

Information on whether production of biodiesel is considered to be covered by the Annex 1 (under 4.1 (b)) and covered already by IPPC or other similar integrated environmental permits at the national level, is provided below. The information is based on the discussion at the April 2006 meeting of the “Interpretation of Annex 1 and ‘Installation’” sub-group of IEG [IEG 2006], as well as the responses from Advisory Group members to a questionnaire.

Member State

Biodieselconsidered under 4.1 (b) or covered by integrated permits similar to IPPC?

Comments

AT Yes No threshold in national legislation, all is considered of “industrial scale”. [Eberhartinger-Tafill, S.]

BE (Wallonie) Yes [Amand, M.]CZ YesDE Yes The know production of biodiesel takes place via

esterification of fatty acids. Therefore, there is no reason, why the production of biodiesel should not be covered by the IPPC Directive. [Cohors-Fresenborg, D.]

EE Yes Produced by transesterification; thus covered by point 4.1 (b) as an ester. Nevertheless, the setting of a threshold value (capacity) is needed to avoiding debate on whether it is industrial scale or not.

FR Yes Production of all biofuel falls under the IPPC Directive requirements, without any threshold. This activity is covered, in the French nomenclature for classified installations, by the activity of industrial production of flammables liquids.

HU Yes Biodiesel production is considered to belong under point 4.1. [Horváth, B.]

IT Yes/No At the moment the main Italian biodiesel production plans are subject to IPPC directive because the process is carried out in refineries, as an IPPC associated activity.Some new (and big) "only biodiesel" installation, however, are going to be build. Due the Italian reading of Annex I (in particular of the term "basic product" in 4.1 chapter), such installations are considered to be outside the IPPC scope (the main product is a "final product", sold to final user to be simply combust).




The relevance of those installations, however, suggest a specific extension of the scope in this case, for example considering in 1.2 category not only mineral oil. [Milillo, A.]

LU n/a No installations. In principle to be covered. [Geimer, C.]

LV (Yes) Taking into account the structure of Directive and materials from which biodiesel is produced, biodiesel production does not fall under this point. In the case of necessity this activity can be included under chapter 6 (Other sectors).However, installations are covered by national B category permit. The requirements in this permit are similar to requirements of an IPPC permit, except that in the case of B category permits the use of “cleaner technologies” is required instead of BAT. [Kramzaka, I.]

MT Yes Chemically, biodiesel comprises a mix of mono-alkyl esters of long chain fatty acids. Thus production of biodiesel is covered by point 4.1b, oxygen-containing hydrocarbons.

NL Yes [Roos, P.]PT No Biodiesel is produced by a chemical reaction

(esterification), usually at industrial scale. So, the decision if biodiesel production is or is not an IPPC activity only depends on the meaning of the term "production of basic chemicals". In biodiesel plants the ester is produced to be used as a fuel, in accordance with the requirements of EN 14124:2003. In the end use (fuel for vehicles) the ester is used under the form of a "blending", that is, in a mixture with conventional fuel or at 100%, and so it can be considered a “final product”. Taking all this into account, and for the purposes of IPPC, the production of biodiesel is not "production of a basic chemical", and therefore not an IPPC activity.

SE Yes Esterification, i.e. chemical processing covered by point 4.1 (b), if it is done on an industrial scale.

SI Yes There is no threshold, but to fall under the scope the product must be sold. Covered because produced by chemical processing (esterification).

SK Yes [Nitschneiderová, H.; Mikulec, J.]UK Yes Biodiesel production in which vegetable oil is trans-

esterified with methanol or ethanol would appear to fall under IPPC as production of esters.

Annex F: Member States’ interpretation regarding bioethanol




Member State

Bioethanol considered under 4.1 (b) or covered by integrated permits similar to IPPC?

Comments

AT Yes In the Austrian transposition act of the IPPC Directive, a separate category for the production of bio-fuels was introduced ("production of biofuels on an industrial scale"). However, basically this category (i.e. the production of biofuels such as biodiesel or bioethanol) under point 4.1 (b) of Annex I (oxygen containing hydrocarbons such as alcohols ...). Chemically speaking, bioethanol is the same substance as ethanol which is an alcohol. Bioethanol is produced by fermentation of starch or sugar from crops. This fermentation is a biotechnological process involving a chemical conversion. The production of bioethanol is carried out on an industrial scale in plants which can be regarded as chemical installations. [Eberhartinger-Tafill, S.]

BE (Wallonie) Yes [Amand, M.]CY n/a No installations. [Demetriou, M.]CZ No Not regarded as IPPC activity, as production by

non-chemical process. Only chemical distilleries are covered under IPPC permits. [Maršák, J.; Slavík, J.]

DE Yes The interpretation of the term "by chemical processing" is that this term covers all types of production using chemical reactions (e.g. chemical, biochemical and biological reactors) for production of chemicals. From our side, this is obvious from the fact that the introduction of section number 4, i.e. the production by "by chemical processing", covers not only sections 4.1 - 4.4, but also section 4.5, which addresses "installations using a chemical or biological process" for the production of basic pharmaceutical products. So, unless there is a embedded contradiction, then "by chemical processing" must be meant in a broad sense.Hence, the production of bioethanol also by fermentation and following distillation is considered to be covered by the IPPC directive. [Cohors-Fresenborg, D.]

DK n/a No production in industrial scale; one company has a pilot plant. [Vestergaard, V.]

EE n/a No existing production installations. [Maidre, T.]




FI Yes Bioethanol production permitted as activity 4.1 (b) of Annex I [Ympäristökeskus 2007]

FR Yes Production of bio fuel falls under the IPPC Directive requirements, without any threshold. This activity is covered, in the French nomenclature for classified installations, by the activity of industrial production of flammables liquids. [IEG 2006]

HU No No, due to current wording of Annex I. [Horváth, B.]

LU n/a No installations. In principle to be covered. [Geimer, C.]

LV (Yes) Not considered an IPPC activity, as it is produced by biotechnology. However, installations are covered by national B category permit. The requirements in this permit are similar to requirements of an IPPC permit, except that in the case of B category permits the use of “cleaner technologies” is required instead of BAT. [Kramzaka, I.]

NL Yes [Roos, P.]PT No “Basic chemical product” is one that is not used

directly by the final (non-industrial) consumer. So, biofuels are not considered to fall under the scope.

RO Yes [Danescu, R.]SE Yes In Sweden integrated environmental permit is

required for bioethanol production installations. [Undén, Å, Werling, K.]

SI n/a No installations, but at the moment bioethanol production is not considered as Annex 1 activity (biological activity). [Zerjav, J.]

SK Yes At present there is no such installation in Slovak Republic. However, one is in preparation and will be IPPC permitted. [Bezuch, B.]

UK Yes Bioethanol production requires an IPPC permit. Production of bioethanol is a Listed (Scheduled) Activity under the Pollution Prevention and Control (England and Wales) Regulations 2000. Section 4.1 Part A(1)(a)(ii). Producing organic chemicals such as organic compounds containing oxygen, such as alcohols. [Vierhout, R.]




Annex G: Main unit processes and unit operations used in industrial organic chemistry [EC 2006c]

Annex H: Number of installations producing pharmaceuticals in MS

Member State

Installations producing pharmaceuticals Comments/Reference(s)

Austria NIA

Belgium 16 [EC 2006b]Cyprus 0 [Demetriou, M]

Czech Republic NIADenmark NIA

Estonia NIAFinland NIA

France 48 [EC 2006b]Germany 94 [EC 2006b]

Greece NIAHungary NIA

Ireland 36 [EC 2006b]Italy NIA

Latvia 4 [EC 2006b]Lithuania 1 [EC 2006b]

Luxembourg 0 [Geimer, C.]Malta NIA

Netherlands 10 (100) Around 100 installations fall under the Dutch business category ‘pharmaceutical products’; 10% fall under the scope of the IPPC [Roos, P.]

Poland NIAPortugal 3 [EC 2006b]




Slovakia 6 (7) 6 of a total of 7 are IPPC permitted [Mikulec, J.; Nitschneiderová, H]

Slovenia 3 [EC 2006b]Spain 70 [EC 2006b]

Sweden NIAUK ~40 [Vincent, R]

TOTAL >> 331 installations*NIA = not information available* The real total number is clearly higher as data from 11 MS was not available. For those MS which are given the number of IPPC pharmaceutical installations and a total figure, the previous has been taken into account here.

Annex I: Summary of discussions on pharmaceutical intermediates by the IEG sub-group

In July 2005 meeting of the “Interpretation of Annex 1 and ‘Installation’” sub-group of IEG [IEG 2005a], regarding Annex 1 activity 4.5, HU queried what is meant by “basic pharmaceutical products”, asking if this means active ingredients, and by “chemical or biological process”. DE suggested that some intermediates, as well as active ingredients, could be considered basic pharmaceutical products. UK thought that specific guidance on this point would be helpful, commenting that its Environment Agency would not generally consider intermediates as basic pharmaceutical products, but that production of intermediates would normally still fall under production of organic or inorganic chemicals.

AT – all pharmaceutical products are included in 4.5.

Further, AT contested the view of DE (see below), arguing that pharmaceutical intermediates were important and would not necessarily be covered by 4.1 or 4.2, and should be covered under 4.5. [IEG 2005b]

DE – ‘basic pharmaceutical products’ means active ingredients but not intermediates, since with intermediates it would not always be inevitable that they would be used only for pharmaceutical products. The production of intermediates would however fall under 4.1. [IEG 2005b]

HU – basic pharmaceutical products means active pharmaceutical agents and intermediates. Formulation is not included. [IEG 2005b]

IE – a basic pharmaceutical product means an active pharmaceutical agent but not an intermediate. However, a plant producing intermediates may fall under another activity description, e.g. 4.1. [IEG 2005b]

IE additionally noted that considering production of pharmaceutical intermediates only under 4.1 and 4.2 would again raise the question of whether biological




processing counts as chemical processing for these activity descriptions, whereas under activity 4.5 biological processing in its own right (without any chemical reaction) is clearly sufficient. [IEG 2005b]

IT – essentially takes the same approach for basic pharmaceutical products as for basic chemicals. Final products are not included. [IEG 2005b]

LV – a basic pharmaceutical product is a raw material that can be used in a further process of production. [IEG 2005b]

PT – a basic pharmaceutical product is one that is not used directly by the final consumer, and would therefore cover active pharmaceutical ingredients that require further transformation. [IEG 2005b]

UK – biological processing means production in a chemical plant by chemical, including biochemical, processing. An activity is therefore covered only if it produces in such a manner an active ingredient, in either crude or pure form. Intermediate products that precede active ingredients would normally fall under production of organic or inorganic chemicals. [IEG 2005b]

The chair concluded that there appeared to be general agreement that production of active ingredients was included, while formulation (e.g. of pills) was not. As regards production of intermediates, most but not all MS considered this excluded from 4.5, but generally covered under 4.1 or 4.2. The MS agreed that it would be better to address this point in the review rather than to produce guidance.


Documents

circabc.europa.eu · Web viewOn the other hand, naming “bioethanol and biodiesel” may cause further confusion between activities of production of basic chemical constituents and