A regulatory tick-list for exporting BPs to the EU

Dr. Marko Sušnik Austrian Federal Economic Chamber Department of Environment and Energy Policy E marko.susnik@wko.at T + 43 (0)5 90 900 4393

What is it that we want to do?

Exporting BPs to the EU - the interaction between BPR and other substance-specific regulations

Considerations

Relevant EU legislation

Practical aspects

Borderlines/dual-use and regulatory framework

National aspects

Considerations

Relevant EU legislation

Practical aspects

Borderlines/dual-use and regulatory framework

National aspects

Relevant EU legislation

Naturally the BPR, we’ve heard and will hear enough about it those days

REACH certainly matters - AS and BP are clearly in its scope

CLP regulation matters too

General safety regulation (GSR) can hide surprises

POP regulation is restricting/banning some AS

Relevant EU legislation

Do not oversee one of those: Regulation on placing on the market of pesticides

− Regulation EC 1107/2009

Legislation on medicinal products (human and vet) − Regulation (EC) No 726/2004 / Directive 2001/83/EC − Regulation (EC) No 726/2004 / Directive 2001/82/EC

Regulation on cosmetics − Regulation (EC) No 1223/2009

Legislation on medical devices − Directive 90/385/EEC / Directive 93/42/EEC / Directive 98/79/EC

Regulation on detergents − Regulation (EC) No 648/2004

Considerations

Relevant EU legislation

Practical aspects

Borderlines/dual-use and regulatory framework

National aspects

Practical aspects - BPR

Naturally the BPR, we’ve heard and will hear enough about it those days

However, the most important considerations for an exporter to the EU are: Do I have a new active substance?

Do I have an old active substance (identified and notified)?

− Is this AS sill in the review process? − Is this AS already processed in the review process?

Great consequences regarding work load

Practical aspects - REACH

REACH certainly matters - AS and BP are clearly in its scope AS which are in conformity with the BPR are considered as

registered according to art. 15 (2) for the specific use in BPs − All other components are not considered as registered! − Any other uses than in BPs are not covered by art. 15 (2)!

Information in the supply chain for BPs is regulated in Title IV − in particular art. 31 (safety data sheet) is relevant (BPR, art. 70) − but also art. 34, e.g. new information on hazards − and art. 36, obligation to keep information 10 years and provide to

authorities on request − art. 33 for SVHCs in articles could be relevant, especially in relation to

treated articles.

Practical aspects - REACH

Let’s have a closer look to the SDS − e(xtended) SDS not relevant for “pure” BP/AS − Consider stepwise changes introduced in 2010 for SDS by

EU reg. 453/2010. The main are: • Until 1 June 2015 (annex I of reg. 453/2010):

o for substances CLP and “old” classification obligatory o for mixtures old classification system obligatory; CLP is

optional • From 1 June 2015 on (annex II of reg. 453/2010):

o for substances and mixtures CLP classification is obligatory; old system is history with a small exemption

• Until 1 June 2017 latest: o mixtures on the market before 1 June 2015 can be still sold

with the “old” SDS; then the old system is really history

Practical aspects - REACH

Obligations for DUs according to Title V relevant − User of BPs/AS are Downstream Users according to REACH − Explicit duty of care (art. 37 (5)) − notification of new (non BP-uses?) to ECHA or the supplier in principle

relevant

Restrictions according title VIII apply also to BPs/AS if not exempted on an individual base

Authorisation title VII does not apply to uses of substances as BPs/AS (article 56(4))

Practical aspects - CLP

CLP regulation matters Classification, labelling and packaging rules apply

to BPs and AS − However, some exemptions and special treatment, e.g.:

• review and update of C&L linked to BPR; • labelling of soluble packaging for single use not

relevant for BPs/AS − Additional rules/elements in BPR, art. 69 − Transitional period can be used: 1.6.2015 (+2a sell-off)

AS are normally in the scope of harmonised classification (article 36(2))

Relevant EU legislation - CLP

Any hazardous substance in a BP needs to be notified to the C&L-inventory once placed on the market (=imported) − No threshold for the notification! − Notification must be performed latest 1 month after

placing on the market. − Via REACH-IT; also IUCLID or XLS-file can be used for

dossier preparation. − The notification requires quite a lot of information.

Do not underestimate the work-load!

Relevant EU legislation - CLP

Coming next: recipe-notification for mixtures, also many BPs, according art. 45 − Information relating to emergency health response. − Need to disclose certain concentration ranges of

substances, including confidential-claimed names. − Additional labelling element – UPI, UFI

− Probably not before 2015 and then transitional periods expected.

Practical aspects – GSR & POP

General safety regulation (GSR) can hide surprises In particular restrictions on a case-by-case basis

for AS are possible, e.g. n-DMF

RAPEX could be relevant for non-conform treated articles

POP regulation is restricting/banning some AS That concerns very problematic substances (e.g.

1st generation organochlorine insecticides) and is based on the Stockholm convention

Practical aspects - fees

Fee-calculation is not straight forward; 3 elements have to be considered: ECHA-fees according EU regulation 564/2013

− For ECHA’s involvement, e.g. accepting dossiers and forwarding them to MSCA or union authorisations.

Annual fee according EU regulation 564/2013 − For… I am not sure…

National fees based on national implementing law: − That means 28 pieces of them! − Some MS have also annual national fees. − ECHA-guidance should promote harmonisation in that

sector, let’s see how that works.

Considerations

Relevant EU legislation

Practical aspects

Borderlines/dual-use and regulatory framework

National aspects

Borderlines/dual-use and regulatory framework

General remarks In principle the BPR regulates all BPs and treated articles,

but there are exemptions in art. 2.

However, these exemptions are a bit fuzzy. The BPR does not exempt substances referred to under art. 2 from being BPs, but only that they are exempted from provisions under defined conditions.

Problems can arise: − due to overlaps in legal definitions with other EU legislation; − due to dual-use. Knowledge on the supply chain is very important. In the end the applicant has to take the decision what the intended use of the product is.

Some guidance by the European Commission and ECHA are available.

Borderlines/dual-use and regulatory framework

Make sure your BP is not (also) a pesticide Check the intended use and place of the specific product.

Pesticides are biocides:

− the use of protecting plants is crucial

Crucial elements will be: − is the product used for protecting plants or − are there other biocidal uses to? Danger of dual-use very high (e.g. protection of crop and/or wine-cellar from mice).

Overlaps probable/possible in e.g. following PTs: − PT 2: disinfectants and algaecides not intended for direct

application to humans or animals − PT 14: rodenticides − PT 19: repellents and attractants

Borderlines/dual-use and regulatory framework

Make sure your BP is not a medicinal product for humans or animals Check the definitions and the intended use of the specific product.

Uses probably very similar:

− both used on skin for killing e.g. parasites However, no dual-use possible, since MP always wins the trick, (if no other uses outside MP-law).

Crucial element will be, if there is a medical claim/indication, e.g.: − use to disinfect wounded skin MP − use on intact skin BP

Overlaps probable/possible in e.g. following PTs: − PT 1: disinfectants for human hygiene − PT 3: disinfectants for veterinary hygiene − PT 19: repellents and attractants

Borderlines/dual-use and regulatory framework

Check cosmetic products with biocidal properties Define the main function, e.g.:

− soap and main cosmetic function CP − soap and main biocidal function BP − soap and equal cosmetic and biocidal function CP and BP

Dual-use probability is obvious. Equally important CP and BP functions are regulated by both legislations within their scope, e.g. sun-blocker with repellent against mosquitos: − repellent function covered by BPR − sun-blocker function covered by CPR

Overlaps probable/possible in e.g. following PTs: − PT 1: disinfectants for human hygiene − PT 19: repellents and attractants

Borderlines/dual-use and regulatory framework

Make sure your BP is not a medical device Consider

− the purpose of the product and what it is marketed for and − what is the mode of action.

Only small parameters define the relevant legislation. E.g. disinfectant is generally under the BPR, but used with a specific device it can fall in the scope of the MDR.

Overlaps probable/possible in e.g. following PT: − PT 2: Disinfectants and algaecides not intended for direct

application to humans or animals.

Borderlines/dual-use and regulatory framework

Detergents with biocidal properties In the scope of both - DR and BPR.

DR has some exceptions for elements that are covered by

the BPR (e.g. testing requirements, assessment)

Overlaps probable/possible in e.g. following PT: − PT 2: Disinfectants and algaecides not intended for direct

application to humans or animals

Considerations

Relevant EU legislation

Practical aspects

Borderlines/dual-use and regulatory framework

National aspects

National aspects

some national rules – example Austria Legal base is the BP-act “Biozidproduktegesetz” (BGBl. I Nr. 105/2000)

− competent authority BMLFUW (Bundesministerium für Land- und Forstwirtschaft, Umwelt und Wasserwirtschaft)

− national BP-inventory (http://www.biozide.at/ms/biozide/biozid_produkte/biozideprod_register/)

− national regime for specific hazardous BPs (e.g. toxic, STOT) including restricted access for the public

− no authorisation for PT 15, 17 or 20 − SDS-notification for mixtures to national environmental authority (Chemikaliengesetz) − regulations for national restrictions possible − enforcement by the regional authorities

Fee regulation: − Biozidgesetz-Gebührentarifverordnung I − Biozidgesetz-Gebührentarifverordnung II − new regulation is on the way

National aspects

some national rules – example Germany Legal base is the chemicals act “Gesetz zum Schutz vor gefährlichen Stoffen“

(ChemG – Chemikaliengesetz) (BGBl. I Nr. 28 vom 11.07.2008 S. 1146) − competent authorities:

o Federal Institute for Occupational Safety and Health (BAUA) - Federal Office for Chemicals/Authorisation of Biocides

o Federal Ministry for the Environment, Nature Conservation and Nuclear Safety (BMU)

− national BP-inventory (http://www.baua.de/de/Chemikaliengesetz-Biozidverfahren/Biozide/Produkt/Zugelassene-Biozidprodukte.html)

− pre marketing notification (Biozid-Meldeverordnung) − no authorisation for PT 15, 17 or 20 − labelling and training requirements for PT 8 − other national restrictions possible − enforcement by the regional authorities

Fee regulation: − Chemikalien-Kostenverordnung

National aspects

some national rules – example Slovenia Legal base is the BP-act “Uredba o izvajanju uredb (EU) o dostopnosti

biocidnih proizvodov na trgu in njihovi uporabi“ (Uradni list RS, št. 20/14) − competent authorities: National Chemicals Bureau − national BP-inventory

(http://www.uk.gov.si/fileadmin/uk.gov.si/pageuploads/pdf/RBP_30.jun.2014.pdf) − approval for activity for hazardous chemicals (Zakon o kemikalijah – Chemicals act) − legal entity in Slovenia necessary − enforcement by chemical inspection

Fee regulation − annex to BP-act

National aspects

example Austria − approval of AS, 3 PT: € 332.825,- / soon € 426.000,-??? − authorisation or BP: € 16.540,- to 36.540,- / soon € 90.000,-??? − authorisation of BP-family: € 20.540,- to 40.540,- / soon € 45.000,-??? − mutual recognition BP: € 4.330,- / soon € 8.100,-???

structures of the legal acts are pretty different ECHA fees not included!

example Germany

− approval of AS, 3 PT: € 284.800,- − authorisation of BP: € 50.000,- − authorisation of BP-family: € 75.000,- − mutual recognition BP: € 15.500,-

some national fees example Slovenia

− approval of AS, 3 PT: € 233.800,- − authorisation of BP: € 13.500,- − authorisation of BP-family: € 25.800,- − mutual recognition BP: € 2.500,-

National aspects

overview national fines and enforcement actions example Austria

− up to € 20.180,- / in case of recurrence up to € 40.360,- − seizure of products − preliminary mandatory and safety measures

example Germany − imprisonment up to 2 years − imprisonment up to 5 years for compromising health, life or

good of significant value − fines

example Slovenia − from € 1.000,- up to € 30.000,- − preliminary restrictions by enforcement

Thank you for your attention.

Dr. Marko Sušnik

Wirtschaftskammer Österreich (WKÖ) Abteilung für Umwelt- und Energiepolitik

Austrian Federal Economic Chamber Department of Environment and Energy Policy

T +43 (0)5 90 900-4393

E marko.susnik@wko.at

H www.wko.at/reach