Status and obligations of Serbian exporters to EU of substances, formulations and articles

TAIEX workshop Beograd, 31.maj 2012

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Status and obligations of

Serbian exporters to EU

of

substances, formulations and articles Simona Fajfar


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REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)

Legal text (Regulation published in EU Official Journal Number 1907/2006), consolidated version available at

http://echa.europa.eu/web/guest/regulations/reach/legislation


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Who is legally responsible?

Exporters of substances, mixtures or articles has no legal obligation

EU manufacturer, importer into EU and only representative are the one who have legal obligation

EU producer of articles/importer of articles


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But to export into EU

Importer is the one who needs to fulfill the legal requirements of REACH and CLP (Classifications, Labelling and packaging) regulations

The obligations for importers are the same as for EU manufacturers

There is an option to have an only representative who is appointed by non-EU manufacturer


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Importer

means any natural or legal personmeans any natural or legal person (‘the legal entity’ established within the EU who is responsible for import.

In many instances the ultimate receiver of the goods who is responsible for the import.


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Definitions: Only representative

Only representative: means a natural or legal person established in the EU and appointed by a manufacturer, formulator or producer of an article established outside the EU to fulfil the obligatioins of importers (Article 8).


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Definitons: substance

Substance: means a chemical element and its compounds. The term substances includes both substances obtained by a manufacturing process (for example formaldehyde and methanol) and substances in their natural state.

The term substance also includes its additives and impurities where this are part of its manufacturing process, but excludes any solvent which can be separated without affecting the stability of the substance or changing its composition.

Detailed guidance on substances and substance identity can be found in the Guidance on substance identification.


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Definitions: Mixture

Mixture: means a mixture or solution composed of two or more substances.

Typical examples of mixturers under REACH includes paints, varnishes and inks.

REACH obligations apply individually to each of the substance contained in the mixture depending on whether the individual substances are within the scope of REACH.


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Definitions: Article

Article: is an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition (e.g. manufactured goods such as textiles, electronic chips, furniture, toys etc.).


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Obligation to register

It is always a substance which has to be registered and not a mixture or an article

Registration is done always per registrant/a legal entity

Company with more than one legal entity/more than one registration but one submission of a dossier


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Obligation to register

All substances manufactured or imported into (EU) in tonnage ≥ 1 tonne/year/manufacturer or importer

Substance as such Substance (-s) in a mixture Substance in an article (in case when the substance

is present in an article in quantities ≥ one tonne or more per year/per producer and intended to be released under normal or reasonable conditions)


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Registration

Article 5

NO DATA NO MARKET


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Examples

Example of a glue formulated in Serbia and exported to Slovenia

Example of Article with intentional release


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Which substances need to be registered?

“phase-in substances”• EINECS list• substances manufactured in EU, but not put on the EU market after 1.6.1992• “no longer polimers”

“non phase-substances” New substances

Substance was not yet put on EU market


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Obligation if you are exporting a substance Registration by importer or only representative

If a substance is a “phase in substance” and pre-registration was done by importer or only representative:

The registration needs to be done within deadline (depending on a tonnage level)

If a substance is a “non-phase in substance” than it has to be registered before to be put on a market.

Inquiry process is needed in that case.


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Other REACH obligation for export of a substance Is the substance you are exporting into EU under

Authorisation regime? Annex XIV of REACH where Substances which

are subject to an authorisation are listed Transitional period until when the substance can

still be used without an authorisation


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Obligation if exporting a mixture

Exporter to help an importer on data about the content of substances in a mixture is important

Are they exceeding 1 tonne level? If yes, than registration for each individual

substance is needed If not than you can export into EU your

formulation with no obligation to register


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Obligation if exporting a mixture

Is any of the substances subject to an authorisation?

Is any of the substances subject to a Restriction? All substances which are under restriction are

listed in Annex XVII Importer has an obligation to communicate

information down the supply chain


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Obligation if exporting an article

If you have article with intentional release and tonnage ≥ one tonne; registration of a substance is needed

If no intentional release than NOTIFICATION in accordance to REACH applies

REACH Article 33 obligation

When substance is put on a candidate list and a list is published by ECHA information about a substance has to be communicated if the content is at least 0,1%


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Obligation to notify to ECHA

In accordance with REACH Article 7 Any producer or importer of article should

notify(a) The substance is present in articles in

quantitites totalling over one tonne or more/year

(b) The substance is present in concentration ≥ 0,1%


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Obligation if exporting an article

REACH Article 33 This information should be at least the name of a

substance “ This article contains …” Example of HBCDD substance Restrictions which are laid down in Annex XVII

of REACH Is there a need to make an analysis for all those

substances which are included in the Annex XVII?


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Pre-preregistration

1.6 – 1.12.2008 for phase-in substances extended deadline for registration for “phase in substances” (2010, 2013 in 2018)


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Pre-registration is officially over But in exceptional cases still possible

Importer to proof that after 1.12.2008 is for the first time importing of a phase in substance (tonnage≥ 1t/year/manufacturer)

Importer to proof that after 1.12.2008 is for the first time importing articles i/u izdelke (substance to be released, ≥ 1tonne/year/ legal entity)

At the latest 6 months after production/importing exceeds one tonnage level and At least 12months before relevant transitional deadline for registration.

Is there still possible to pre-register after 1. 12. 2008?


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Deadlines for registrations

Extended deadlines only for Phase in substances if pre-registrated!

CMR kat. 1,2 > 1 t/l (1.12. 2010)

R50-53 substances > 100 t/l (1.12. 2010)

Phase in substances > 1000 t/l (1.12. 2010)

Phase in substances > 100 t/l (1.06. 2013)

Phase in substances > 1 t/l (1.06. 2018)Obligation to register are inforced since 1st June 2008.


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Exemptions from REACH

All substances • Phase-in substances• Polymers• Monomers• Intermediates (with limited

exposure potential)• R&D substances• Substances in articles• Pesticides• Biocides• Human or veterinary drugs• Food or feeding stuffs

Except• Radioactive substances• Substances subject to

customary inspection• Non-isolated intermediates• Carriage of dangerous

substances• Waste• Defence (up to Member

State)

…where taken care of in other legislation…


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Substances exempted from registration obligation

IT IS IMPORTANT TO CHECK IF A SUBSTANCE IS EXEMPTED FROM REGISTRATION OBLIGATION


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Substances which are considered as being Registered

Plant protection products

- Active substances included into Annex I of Directive 91/414/EGS

Biocidal products:

-Active substances included into Annexes I, IA and IB of Directive 98/8/ES

Substances which has been already notified in an EU system before REACH (Directive 67/548/EEC)


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REGISTRATION dossier

Consists from :

→ tehnical documentation - for all substances in a tonnage ≥ 1t/l - to be prepared in a IUCLID 5 format

→ Chemical Safety Report - needed when tonnage of a substance ≥ 10t/l


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Registration dossier

Technical dossierTechnical dossier DATA about a substance

Chemical Safety Report – Separate document

IUCLID dossier

Submission throughREACH-IT

ECHA

Chemical Safety Report for tonnage ≥ 10t


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Technical documentation

1. General information about registrant (legal entity who has an obligation to register

2. Identification of a substance IUPAC/other name, EINECS/ELINCS number, CAS

number, degree of purity (%), inpurities which are present in %)


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Technical documentation

3. Information about the production and use (-s) of substances

4. Classification and labelling

5. Instructions for safe use

Chemical Safety Report

Safety data Sheet


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Forum for exchange of Data(SIEF)

Who can be member of a SIEF non- EU manufacturer can also be involved in the SIEF


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Separate submission of DATA

Registrant has to submit

Data about manufacturer/importer Identity of a substance Information about manufacturing and use

of a substance Exposure data


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Joint submission of data

Lead registrant

Data on dangerous propertiesof a substance Classification and labelling ofsubstance Study summaries Robust study summaries Testing strategies (if relevant)

- Reduction of costs - Reduction on animal testing


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Fees for the registration

Level of fee depends on:o tonnage level (o size of the company (small, medium, micro, large)o type of submission (individual/joint)


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A network of EU legislation relies on classification in one way or the other

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• Consequences of classification are greater than just a hazard communication label or a safety data sheet in that it also has a direct effect on the management of associated risks.

HazardClassification

• Workplace

• Export and Import • Hazardous waste

• Major-accidenthazards

• Transport

• Consumer products

• REACH

• Cosmetics • Detergents

• Plant protection

• Biocides

• Eco-label

• Volatile Organic Compounds

NOTE! The classification system is hazard based. For it to work it is outmost important to keep classification based on intrinsic hazardous properties and not on downstream consequences.


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CLP DEFINITIONS

* Manufacturer “any natural or legal person established within the Community who manufactures a substance within the Community”

* Importer “any natural or legal person established within the Community who is responsible for import”

* Downstream user “natural or legal person established within the Community, other than manufacturer or importer, who uses a substance, either on its own or in a mixture, in the course of industrial or professional activities”

* Distributor “natural or legal person established within the Community, including retailer, who only stores and places on the market a substance, on its own or in a mixture, for third parties”

– * Same as REACH


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Timelines 20/1/200920/1/2009 1/12/2010 1/12/2010 1/6/2015 1/6/2015

Substances: CPL * CLP

Mixtures: CPL * CLP **

SDS: CPL & CLP

CLP**

CPL: (Directives:67/548/EEC & 1999/45/EC)CLP Regulation

Mixtures: CPL

* Voluntary early application of CLP

** Derogation for already placed on the market :– substances until 1/12/2012– mixtures until 1/06/2017


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ROLES & OBLIGATIONS

ClassifyClassify LabelLabel PackagePackage NotifyNotify Keep info Keep info 10 yrs10 yrs

ManufacturerManufacturer ImporterImporter Downstream UserDownstream User ** **** DistributorDistributor ******

*Change composition - classify. If not, use supplier’s **Notification to poison centre***Distributor may use classification of another actor


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HVALA

Documents

Status and obligations of Serbian exporters to EU of substances, formulations and articles