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

1. Status and obligations of Serbian exporters to EU of substances, formulations and articles • Simona Fajfar

2. 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

3. Who is legally responsible? • Exporters of substances, mixtures or articles has no legal obligation • EU manufacturer, importer into EU and only representative are the onewho have legal obligation • EU producer of articles/importer of articles

4. 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

5. Importer • means 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.

6. 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).

7. 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.

8. 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.

9. 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.).

10. 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

11. 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)

12. Registration Article 5 NO DATA NO MARKET

13. Examples • Example of a glue formulated in Serbia and exported to Slovenia • Example of Article with intentional release

14. 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

15. 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.

16. 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

17. 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

18. 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

19. 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%

20. Obligation to notify to ECHA • In accordance with REACH Article 7 • Any producer or importer of article should notify • The substance is present in articles in quantitites totalling over one tonne or more/year • The substance is present in concentration ≥ 0,1%

21. 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?

22. Pre-preregistration • 1.6 – 1.12.2008 • for phase-in substances • extended deadline for registration for “phase in substances” (2010, 2013 in 2018)

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

24. 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.

25. 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… Exemptions from REACH

26. Substances exempted from registration obligation IT IS IMPORTANT TO CHECK IF A SUBSTANCE IS EXEMPTED FROM REGISTRATION OBLIGATION

27. 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)

28. 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

29. Registration dossier • Technical dossier DATA about a substance IUCLID dossier ECHA Chemical Safety Report – Separate document Submission through REACH-IT Chemical Safety Report for tonnage ≥ 10t

30. 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 %)

31. 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

32. Forum for exchange of Data (SIEF) • Who can be member of a SIEF • non- EU manufacturer can also be involved in the SIEF

33. 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

34. Joint submission of data Lead registrant • Data on dangerous properties of a substance • Classification and labelling of substance • Study summaries • Robust study summaries • Testing strategies (if relevant) - Reduction of costs - Reduction on animal testing

35. Fees for the registration • Level of fee depends on: • tonnage level ( • size of the company (small, medium, micro, large) • type of submission (individual/joint)

36. A network of EU legislation relies on classification in one way or the other • 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. 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. 36

37. 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

38. Timelines Substances: CPL * SDS: CPL & CLP CLP** CLP Mixtures: CPL Mixtures: CPL * CLP ** CPL: (Directives:67/548/EEC &1999/45/EC) CLP Regulation **Derogation for already placed on the market : – substances until 1/12/2012 * Voluntary early application of CLP – mixtures until 1/06/2017 20/1/2009 1/12/2010 1/6/2015

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

40. HVALA