1. REACH in the eyes of a downstream user The changing market of cosmetic ingredients Aleksandra Sołyga-Żurek Warsaw, 23.XI.2011

2. Dr Irena Eris Cosmetic Laboratories The Dr Irena Eris Cosmetic Laboratories were established in 1983 with a single employee and producing just one kind of cream. Today, it is a thriving company with 700 employees, both in production and services. It manufactures 1,45 million units of products monthly, exports its products worldwide. The brand of Dr Irena Eris is one of the most valuable and best-known Polish brands

3. Dr Irena Eris Cosmetic Laboratories R&D Dr Irena Eris Center for Science and Research PRODUCTS Face and body care cosmetics SERVICES Dr Irena Eris Skin Care Institutes chain Dr Irena Eris Hotel & SPA Krynica Zdrój Dr Irena Eris Hotel & SPA Wzgórza Dylewskie

4. Our main obligations as a downstream user Identify and apply appropriate measures to control the risks communicated in safety data sheet or other information supplied with non- dangerous sub-stances or preparations Inform suppliers of any new information on hazards, including classification and labeling Ensure that every cosmetic ingredient we use is: -registered, or -pre-registered and still before its registration deadline, or -exempted from REACH

5. Gathering information More than 3000 ingredients. Obtaining definite information was not easy for the first years. The first question was: will all the ingredients we use be pre-registered?

6. Gathering information Obtaining information has gradually become easier. Some cosmetic ingredients are already registered (however, verifying the information is still not easy). Many suppliers refuse to provide any definite statements.

7. Gathering information A complex database is necessary to keep track. Ingredient data (supplier, name, number, INCI, CAS, EINECS, other, safety data, classification, tonnage (if known); Registration data (exempted?, registered?, pre-registered?, registration number?, registration deadline?, present on ECHA lists?, current Safety Data Sheet?)

8. Registration - uses

9. Influence on our choice of ingredients Identified uses – may force us to choose more expensive ingredients. Ingredients produced outside of European Union. Animal testing problem – probably specific for cosmetic products. Influence on innovation?

10. Annex XV This Annex lays down general principles for preparing dossiers to propose and justify: – harmonised classification and labelling of CMRs, respiratory sensitisers and other effects, – the identification of PBTs, vPvBs, or a substance of equivalent concern, – restrictions of the manufacture, placing on the market or use of a substance within the Community. Safety for human health is within the scope of cosmetic legislation. Safety for the environment is not.

11. Octamethylcyclotetrasiloxane – D4 (PBT and vPvB?) and Decamethylcyclopentasiloxane – D5 (vPvB?) – currently under evaluation. Cosmetic industry is the largest user in end products. Submission of an SVHC dossier will result in new obligations for the industry. It will probably also cause negative media impact. Restrictions (annex XVII), authorization (annex XIV), ban in cosmetic products? Finding suitable alternatives is problematic. The application of the final regulatory measures will take years.

12. Changes on the cosmetic ingredients market Increase in prices (although REACH is definitely not the only cause). Availability of existing ingredients has not changed significantly (this may still change, as many ingredients have registration deadlines in 2018). A decrease in new, innovative ingredients is visible (but again, REACH is not the only cause).

13. Main advantages Better environment protection. Development of testing alternatives. The main impact on cosmetic industry is still from Regulation 1223/2009.

14. A ‘legislative calendar’ for a cosmetic manufacturer 1 December 2010 CMR in cosmetics (Regulation 1223/2009); Deadline for registration of CMRs – 1 tonne, N/R50-53 – 100 tonnes, others – 1000 tonnes (REACH); deadline - classification and labeling for substances (CLP) January 2012 on-line notification of cosmetic products starting (Regulation 1223/2009) January 2013 Nanomateria ls in cosmetics – notification obligatory (Regulation 1223/2009) 1 June 2013 Deadline for registration – 100 tonnes (REACH) 1 June2018 Deadline for registration – 1 tonne (REACH) 1 June 2015 Classification and labeling for mixtures (CLP) 1 December 2012 New labeling on all substances (CLP) 1 June 2017 New labeling on all mixtures (CLP) 2012 Publication of guidelines on claims, changes in preservative regulations (Regulation 1223/2009); siloxanes (REACH) 1 July 2013 On-line notification of cosmetic products mandatory, new dossier, labeling changes etc. (Regulation 1223/2009)

15. Impact on cosmetic industry The cosmetic industry in general is well prepared. Seminars, conferences, guidance. Many smaller companies may still be unaware of new obligations.

16. Thank you for your attention