1. Key elements of the concepts and approaches within the EU in the chemical sector Dr. Marcus Moreno-Horn TAIEX: Workshop, Yerevan 2-3 May 2011 Federal Office for Chemicals

2. Yerevan, 02-03 May 2011 2 Overview Introduction Aim and principals Key elements Structured Testing Communication of hazards Protection Identification of SVHC Authorisation Restrictions Key concepts Harmonisation Mutual Acceptance Exemptions

3. Yerevan, 02-03 May 2011 3 Aim DE: ChemG § 1 Aim Aim of this law is to protect human and the environment against harmful effects of dangerous substances and preparations ….. EU: Regulation 1907/2006 (REACH) Art. 1 (1) Aim and scope The purpose of this Regulation is to ensure a high level of protection of human health and the environment,……

4. Yerevan, 02-03 May 2011 4 Historical Developement  First time broad instructions by law COUNCIL DIRECTIVE (67/548/EEC) of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances Duty of labelling dangerous substances by: hazard symbol; risk statement (R- phrases) safety statement (S- phrases), design of label

5. Yerevan, 02-03 May 2011 5 Principles of Chemical Law Knowledge about the dangerous properties is important for a safe use with substances Communication H 351 May cause cancerDanger

6. Yerevan, 02-03 May 2011 6 Communication about substance hazards requieres profund knowledge aboute relevant properties  Identification of hazardous properties Principles of Chemical Law

7. Yerevan, 02-03 May 2011 7 Some properties are easy to identify For example: Acute toxicity Explosives Corrosive properties Identification of hazardous properties Principles of Chemical Law

8. Yerevan, 02-03 May 2011 8 But other properties are not easy to identify For example: carcinogenicity PBT- and vPvB properties endocrine disruptors Identification of hazardous properties Principles of Chemical Law

9. Yerevan, 02-03 May 2011 9 An adequate classification and labeling of substances requieres therefore a systematic assessment of the properties of the substance  Testing of chemicals (animal testing) Identification of hazardous properties Principles of Chemical Law

10. Yerevan, 02-03 May 2011 10 The three pilars of chemical regulation 1.Assessment of hazards and intrinsic properties (Structured testing and evaluation) 2. Communication of hazardous properties (Classification & labelling, SDS) 3.Provisions of Protection (e.g. ban, restriction, authorisation)

11. Yerevan, 02-03 May 2011 11 Overview Introduction Aim and principals Key elements Structured Testing Communication of hazards Protection Identification of SVHC Authorisation Restrictions Key concepts Harmonisation Mutual Acceptance Exemptions

12. Yerevan, 02-03 May 2011 12 Assessment What kind of Information? SECTIONS PHYSICO-CHEMICAL INFORMATION TOXICOLOGICAL INFORMATION ECOTOXICOLOGICAL INFORMATION Structured testing No data, no Market

13. Yerevan, 02-03 May 2011 13 PC - DATATOX- DATAECOTOX- DATA < 1 t ** + 1 - 10 t/a +++ 10 -100 t/a+++ 100 -1000 t/a * +++ 1 000 t/a * +++ * testing proposals (REACH- Regulation);** placing on the market (CLP-Regulation) The Tonnage-Triggered Approach Structured testing

14. Yerevan, 02-03 May 2011 14 The Tonnage-Triggered Approach Physical-chemical, toxicity and ecotoxicity properties 1 - <10 t/a: Annex VII 10 - <100 t/a: Annex I+ VII + VIII 100 - <1000 t/a: Annex I+ VII + VIII + IX ≥ 1000 t/a: Annex I+ VII + VIII + IX + X Standard Information Requirements for the purpose of registration REACH Regulation 1907/2006 Structured testing

15. Yerevan, 02-03 May 2011 15 1 - <10 t/a: Standard Information Requirements PHYSICO-CHEMICAL Data: 7.1. State of the substance at 20 °C and 101,3 kPa 7………………… 7.14. Granulometry TOXICOLOGICAL INFORMATION: 8.1. Skin irritation 8…………………… 8.5. Acute toxicity: 8.5.1. By oral route ECOTOXICOLOGICAL INFORMATION: 9.1. Aquatic toxicity 9.2. Degradation: 9.2.1. Biotic 9……………………. The Tonnage-Triggered Approach Structured testing

16. Yerevan, 02-03 May 2011 16 Article (Jurists) -sets provisions and refers to Annex For example „Tests have to be performed“ Annex (Scientist) -describes in detail the provisions For example „ Acute toxicity has to be investigated“ and refers to test methods either to Reg. (EC) Nr. 440/2008 (priviously Annex V (67/548/EEC) or directly to OECD (Guidelines for the Testing of Chemicals) (majority of the methods described are based on the OECD Test Guideline) Guidelines (Scientist) -describes test method For example „Part B: B.4. Acute toxicity (OECD TG 404 (2002)) Organisation of provisions Structured testing

17. Yerevan, 02-03 May 2011 17 OECD Test OECD Guidelines for the Testing of Chemicals http://www.oecd.org/document/40/0,3746,en_2649_34377_37051368_1_1_1_1,00.html The OECD Guidelines for the Testing of Chemicals is a collection of the most relevant internationally agreed test methods used by: - government, - industry and - independent laboratories to determine the safety of: chemicals and chemical preparations, including pesticides and industrial chemicals. They cover tests for the physical-chemical properties of chemicals, human health effects, environmental effects, and degradation and accumulation in the environment.

18. Yerevan, 02-03 May 2011 18 REACH Article 25 (Objectives and general rules) „…..avoid animal testing ….“ few words great impact Instruments: Title III (data sharing) Annex IX and X (testing proposals) Waiving Mutual data acceptance (Art. 15) …avoid animal testing…

19. Yerevan, 02-03 May 2011 19 The generated data are the basis for the evaluation Exposition / Toxicological potential = Risk Risk Mangement Principles of Chemical Law Evaluation

20. Yerevan, 02-03 May 2011 20 The „Label“ communicates the basic information The „Safety Data Sheet“ contains more detailed information for the use of chemical products Communication of hazards Label Pictogram Signal word Hazard code Danger H 311 Attention H 223 Danger H 314

21. Yerevan, 02-03 May 2011 21 The „Label“ communicates the basic information The „Safety Data Sheet“ contains more detailed information for the use of chemical products Communication of hazards SDS REACH Article 31 in combination with Annex II (Regulation 453/2010) Guide to the compilation of SDS 16 Sections e.g. SECTION 2: Hazards identification 2.1. Classification of the substance or mixture

22. Yerevan, 02-03 May 2011 22 C&L Aim and Purpose: Substances should be classified joint and consistent Instruments: – C&L Dossier proposals for harmonisation of the classification and labelling of substances (Authorities) – Notification to the Classification & Labelling Inventory of the ECHA Online Database (Industry) Harmonised Classification and Labelling

23. Yerevan, 02-03 May 2011 23 Overview Introduction Aim and principals Key elements Structured Testing Communication of hazards Protection Identification of SVHC Authorisation Restrictions Key concepts Harmonisation Mutual Acceptance Exemptions

24. Yerevan, 02-03 May 2011 24 Criteria (Art. 57): CMR-Substances category 1a and 1b; (Annex Vl; CLP) PBT- and vPvB- Substances; (Annex XIII) equivalent concern 57 (f) C: cancerogenic or M: mutagenic or R: toxic for reproduction P: persistent and B: bioaccumulative and T: toxic e.g. Substances, influencing the endocrine system or PBT- and vPvB-like properties Identification of SVHC

25. Yerevan, 02-03 May 2011 25 Identification of SVHC No obligations Art. 7,31,33… Art. 56 substance is identified as SVHC Art. 57 criteria fullfilling (Art. 59) Identification procedure Registry of intention Candidate status Annex XIV Annex XV Dossier http://echa.europa.eu/chem_data/reg_int_tables/reg_int_en.asp?substance_type=SVHC&substance_state=current 46 Entries Feb 2011 Regulation (EU) Nr. 143/20116 Entries Feb 2011 For example: Substance is listed in Annex VI of CLP and classified as Carc. Cat. 1a or 1b (Art. 59 (2))

26. Yerevan, 02-03 May 2011 26 Authorisation Authorisation for industrial chemicals Substance listed in Annex XIV REACH (EG) Nr. 1907/2006 must not be placed on the market or used, unless: Authorisation is granted for the use of the substance as such.. What to do ? Application for authorisation (ECHA) (fees)

27. Yerevan, 02-03 May 2011 27 Industry initiates : inclusion of active substance into Annex I (Directive 98/8/ EC) (Evaluation of data by authorities) What to do ? Application for authorisation of biocidal product containing active substance (Member state) (fees) Mutal recognition in other Member states (fees) Similar procedure for PPP (Plant Protection Product) Annex I (Directive 91/414/EEC) The proceedings of authorisation of a Biocidal product Authorisation

28. Yerevan, 02-03 May 2011 28 Protection measure Restriction A Restriction is an Instrument of authorities Legal source – examples: Regulation 850/2004/(EC) on persistent organic pollutants Annex XVII REACH (EG) Nr. 1907/2006 What to ? Comply with conditiones listed in the legal texts

29. Yerevan, 02-03 May 2011 29 Protection measure Restriction Regulation 850/2004/(EC) The production, placing on the market and use of substances listed in Annex I, whether on their own, in preparations or as constituents of articles, shall be prohibited e.g.[Heptachlor; EC No 200-962-3] Annex XVII REACH (EG) Nr. 1907/2006 Shall not be used as substances or in preparations in the treatment of wood. Furthermore, wood so treated shall not be placed on the market. e.g.[ creosote; wash oil ;EC No 232-287-5]

30. Yerevan, 02-03 May 2011 30 Protection measure Adressed Distribution Substances and preparations shall not be sold to the general public Chloroform (CAS No 67-66-3) > 0.1% Restricted to professional Substances which appear in Annex I to Directive 67/548/EEC classified as mutagen category 1…..

31. Yerevan, 02-03 May 2011 31 Overview Introduction Aim and principals Key elements Structured Testing Communication of hazards Protection Identification of SVHC Authorisation Restrictions Key concepts Harmonisation Mutual Acceptance Exemptions

32. Yerevan, 02-03 May 2011 32 Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work German Working Conditions Act (Arbeitsschutzgesetz, 1996) Approximation of laws in the EU Member States, e.g. Approximation of laws

33. Yerevan, 02-03 May 2011 33 Harmonisation Directive 1999/45/EC (DPD) This Directive is addressed to the Member States - national implementation required !! Regulation (EC) 1272/2008 (CLP) This Regulation shall be binding in its entirety and directly applicable in all Member States - no implementation required !! Directive versus Regulation

34. Yerevan, 02-03 May 2011 34 Harmonisation Directive 76/769/EEC (Restrictions) is repealed and inserted in Regulation (EC) 1907/2006 (REACH) as Annex XVII Insertion

35. Yerevan, 02-03 May 2011 35 Overview Introduction Aim and principals Key elements Structured Testing Communication of hazards Protection Identification of SVHC Authorisation Restrictions Key concepts Harmonisation Mutual Acceptance Particular provisions

36. Yerevan, 02-03 May 2011 36 authorisation for biocidal products Biocid Products Animal Test (GLP) Authorisation 98/8/EC (Biocidal Products Directive) Mutual Recognition & Acceptance Member States OECD Members

37. Yerevan, 02-03 May 2011 37 Active substances for use in Biocid Products or Plant Protection Products (PPP) Article 15 REACH Registration (REACH) Mutual Acceptance No further tests for the purpose of registration

38. Yerevan, 02-03 May 2011 38 Data Acceptance and Sharing One substance One animal test One SIEF Registration (REACH) SIEF Substance Exchange Information Forum

39. Yerevan, 02-03 May 2011 39 Particular provisions I) Facilitation of labelling (CLP-1272/2008) shall not apply to substances or mixtures within the scope of Directives 91/414/EEC or 98/8/EC II) SDS (REACH Art.31) must not be provided for cosmetic products as defined in Directive 76/768/EEC III) National ocupational Exposure limits are still binding OEL versus DNEL The exception proves the rule

40. Yerevan, 02-03 May 2011 40 Finally www.reach-clp-helpdesk.de Thank you for your attention!