EU regulatory framework for the Registration, Evaluation and Authorisation of CHemicals REACH status report

Transcription

1 EU regulatory framework for the Registration, Evaluation and Authorisation of CHemicals REACH status report ERA Pro Deco Forum Wiesbaden, Germany, 5 July 2006 Dipl.-Chem. Josef Paul Bernard 1

2 What is the aim of REACH? For the EU Commission, the aim of REACH is to improve the protection of human health and the environment. The transparency for properties of chemicals should be significantly improved. The industry should proactively improve safety and risks in hazardous chemicals. 2

3 Please remember: The basic principle is that enterprises that manufacture or import more than one tonne of a chemical substance per year would be required to register the chemical in a central database. The registration has to include toxicological information and information on the chemical s environmental impact. There are further thresholds (t/a) where more extensive scientific data is required. 3

4 For the details of the basic principles I would like to refer to my presentation given at the Pro Deco Forum 22 June 2005 here in Wiesbaden. My summary was: REACH may have in the current version (06/2005) serious effects on packaging and decorative gravure and all printing methods using small quantities of specific substances. Today I will speak on the developments in the legislation process since June

5 discussion in the EU The EU parliament s ENVI (Environment, Public Health and Food Safety) Committee rejected the proposal (Oct. 2005) to give registration facilities up to 100 t/year. Registration facilities should be limited to up to 10 t/year. New positive proposal: Companies should have the possibility to build consortia for a specific chemical. 5

6 ERA has signed together with EuPIA (European ink manufacturers association), ECMA (European folding carton association), EFE (European flexible packaging association) and six additional Associations a joint position letter on REACH and printing inks. 6

7 The position paper was sent 8th November 05 to the members of the European Parliament. It highlights the importance for less stringent legislation for the categories 1-10 and t/year and the high risk that chemicals will be withdrawn from the market. The document concentrates on the problems of SMEs and packaging and décor printers with REACH. 7

8 The Joint position paper: Effects of REACH on ink manufacturers and ink use and the cover letter will be sent to you, if you mail your address to The document (5 pages) explains the problems in detail. 8

9 One week before the first vote in the European Parliament (17th Nov. 2005), the Christian Democrats = European People's Party (main speaker: Hartmut Nassauer) and the Socialists (main speaker: Guido Sacconi) came to a joint position. Later the third largest group ALDE (Alliance of Liberals and Democrats for Europe) also ratified the agreement at the last minute. 9

10 The key elements of the parties compromise were: An 18-month pre-registration phase with a further six months granted to downstream users Chemicals in the class 1-10 t/year should first be divided by exposure and use categories, to evaluate whether the whole test series is necessary (Risk-based approach) 10

11 The key elements of the parties compromise were: Safety data requirements in the tonne/year range can be dropped if the risks are limited according to the assessment of the Chemical Agency, Helsinki = waiver option Mandatory data sharing under the One Substance, One Registration (OSOR) proposal. Each chemical has to be registered only once. 11

12 On 16 Nov the involved Committees of the European Parliament also agreed on a compromise. The vote on 17 Nov was the biggest, longest and most complicated vote ever held in the EU Parliament. They had over 1000 amendments to vote on. 12

13 Finally 407 MEPs voted for the compromise, 155 against it, 41 abstained and 128 were not present. REACH is now between 1st and 2nd reading in the European Parliament. The EU Parliament and the other involved bodies are preparing for the second reading which is expected in October

14 Same points of the draft REACH proposal were improved, others not: winners and losers were found on all sides. For the substitution and authorization of very toxic substances and CMR (Carcinogenic, Mutagenic and Reprotoxic) substances, the proposed rules were significantly hardened. Important is, that reprotoxic substances are only included if they are in category 1 or 2. 14

15 The importance for the printing industry of Authorisation is limited because printing inks produced in Europe do not contain CMR substances classified as category 1 or 2 (toluene, for example, is category 3). This is a result of the European ink manufacturers commitment not to use such substances. Authorisation is therefore not relevant as long as we do not use CMR cat. 1 or 2 substances. 15

16 The problem is, it could easily happen that some substances undergo the process of new Classification and Labelling and end up with a Cat. 1 or 2 Classification: for example ethanol. 16

17 Criteria for granting an Authorisation are that there are no suitable alternatives and that the socio-economic advantages outweigh the risks and that the risk is adequately controlled. The Authorisations have to be reviewed periodically. 17

18 Important: The rules for substances in articles now apply also for imported articles. (Note: magazines, catalogues, brochures, flyers and inserts are articles by the definition used in REACH). The Chemical Agency can request registration of any substance contained in articles, and notification if the substance presents risks to humans or the environment, or the substance has not been registered for this use. 18

19 In Article 2 of the REACH draft some exemptions were made: waste, food (but not packaging) and in general items which are adequately regulated by other legislation. 19

20 One week later, Commissioners Verheugen (Enterprise) and Dimas (Environment) supported the compromise found by the main political groups in the EU parliament. Dimas said the Commission will support the UK Presidency in trying to find a compromise in the Council before the end of the year. 20

21 28 / 29 Nov REACH was debated in the Competitiveness Council. No voting after Germany obtained a delay. The new German Government had to be established. 13 Dec The UK Presidency compromise proposal was accepted by the European Council. 27 June 2006 The Council of European Environmental Ministers approved the December 2005 compromise. 21

22 The EU Parliament will have the second reading in October After that the Council of European Environmental Ministers will deal with REACH again. In 2007 REACH probably will be ready for publication in the OJ (Official Journal) of the EU. 22

23 What could you do? (I) 1. Take care of present obligations, they all are included in REACH 2. Clarify which substances are in the preparations you use. Which R-phrases do they have? 3. Follow the CEPE exclusion list. = Withdraw toxic and CMR chemicals now. 4. Prepare for the chemicals which may be withdrawn for economic reasons 23

24 What could you do? (II) 5. Collect data for exposure scenarios (purpose of use, quantities) 6. Collect data for dangerous substances in Articles and evaluate if the substances can be released. 24

25 Questions please. 25