1. BOLOGNA - 27 October 2008 1/9 REACh, tanners and the role of Research Centers The example of CTC REACh: Regulation, Evaluation, Autorisation and Restriction of Substances Thierry PONCET Régis LETY tponcet@ctcgroupe.com Tel : 33.472 76 10 05

2. BOLOGNA - 27 October 2008 2/9 Should European tanners read the 840 pages of REACh? Registration information on 40 000 substances > 1t/year/manufacturer Evaluation of 2nd level Evaluation Authorisation Analysis of 1st level Temporary authorisation with obligation of substitution asap manufacturer/importer Echa member states All substances (Pure/preparation/in products) Very high concern substances (CMR, PBT, vPvB)* CMR : Carcinogenic, Mutagenic Reprotoxic I et II PBT : Persistent, Bioaccumulable and toxic vPvB : very Persistent, very Bioaccumulable Restrictions Pre-Registration

3. BOLOGNA - 27 October 2008 3/9 STEP 1- What is a tanner and what to do ? Chemical importer – Pre-registration Downstream user – Inform chemical suppliers that the chemical is used in the tanning industry. Exposer scenario Article manufacturer: – Does the leather sold complies with REACh? Each supplier shall give to the products user at least, the name of the very high concern substances present in the products, if : - CMR 1/2, PBT, vPvB - C > 0.1 % (1 g/kg)

4. BOLOGNA - 27 October 2008 4/9 STEP 1- The answer of Research Centers Chemical importer – Pre-registration Downstream user – Inform chemical suppliers that the chemical is used in the tanning industry. Exposer scenario for the Chemical Report Article manufacturer: – Does the leather sold complies with REACh? Each supplier shall give to the products user at least, the name of the very high concern substances present in the products, if : - CMR 1/2, PBT, vPvB - C > 0.1 % (1 g/kg) The answers of the Research Center – Knowledge Management / Information – Determin what are the substances of Very High Concern in Leather? – Benchmarking on Chemical Testing – Tool and methodologies – How to determin what are the Substances of Very High Concern? – Data Base on Chemical Safety Data based – Data Base on Restricted Substances – Propose Model Letters.

5. BOLOGNA - 27 October 2008 5/9 > What is the candidate list to annexe XIV? Annex XIV will be published on June 1, 2009

6. BOLOGNA - 27 October 2008 6/9 > What are the candidate Substances to annexe XIV? Phtalates (DEHP, DBP, BBP) Chromium VI Chloroalkanes C10-13 Lead Annex XIV will be published on June 1, 2009

7. BOLOGNA - 27 October 2008 7/9 STEP 2 - REACh consequences  Beginning of October: 38 000 Commercial References pre-registrered  CTC’s Chemical Data Base: > 2.400 Commercial References  450 substances used in the Tanning Industry (not exhaustive)  Pre-registration up to November 30th.

8. BOLOGNA - 27 October 2008 8/9 Step 2 – The Answer of Research Centers  Before 30 November 2008  Identify what chemical haven’t been pre-registered  Identify what are the corresponding Commercial References  Alert the Chemical Suppliers  After 30 November 2008  Search for alternative chemicals

9. BOLOGNA - 27 October 2008 9/9 Conclusion  REACh, as most regulations is a constraint for the European Tanners.  Instead of having each tanner doing the job by itself, Research Centrers have to prepare collectivelly their single work by providing  Information  Tools and methodology  Communications, model letters  Research programs