REACH in the eyes of a downstream user The changing market of cosmetic ingredients Aleksandra Sołyga-Żurek Warsaw, 23.XI.2011
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
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 CareInstituteschain Dr Irena Eris Hotel & SPA Krynica Zdrój Dr Irena Eris Hotel & SPA Wzgórza Dylewskie
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 • Ensurethateverycosmetic ingredient we useis: • registered, or • pre-registered and stillbeforeitsregistrationdeadline, or • exemptedfrom REACH
Gathering information • More than 3000 ingredients. • Obtainingdefiniteinformation was not easy for the first years. • The first question was: will alltheingredients we use be pre-registered?
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.
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?)
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?
Annex XV • This Annex lays down general principles for preparing dossiers to propose and justify: – harmonised classification and labelling of CMRs, respiratory sensitisers and othereffects, – the identification of PBTs, vPvBs, or a substance of equivalent concern, – restrictions of the manufacture, placing on the market or use of a substance withintheCommunity. • Safety for human health iswithinthescope of cosmeticlegislation. Safety for the environment is not.
Octamethylcyclotetrasiloxane – D4 (PBT and vPvB?) and Decamethylcyclopentasiloxane – D5 (vPvB?) – currently under evaluation. • Cosmetic industry isthelargestuserinend products. • Submission of an SVHC dossier will resultinnewobligations for the industry. It will probablyalsocausenegative media impact. • Restrictions (annex XVII), authorization (annex XIV), banincosmetic products? • Findingsuitablealternativesisproblematic. • Theapplication of thefinal regulatory measures will takeyears.
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).
Main advantages • Better environment protection. • Development of testing alternatives. • The main impact on cosmetic industry is still from Regulation 1223/2009.
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) 2012 Publication of guidelines on claims, changes in preservative regulations (Regulation 1223/2009); siloxanes (REACH) 1 December 2012 New labeling on all substances (CLP) January 2013 Nanomaterials in cosmetics – notification obligatory (Regulation 1223/2009) 1 June 2013 Deadline for registration – 100 tonnes (REACH) 1 July 2013 On-line notification of cosmetic products mandatory, new dossier, labeling changes etc. (Regulation 1223/2009) 1 June 2015 Classification and labeling for mixtures (CLP) 1 June2018 Deadline for registration – 1 tonne (REACH) 1 June 2017 New labeling on all mixtures (CLP)
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.