REACh stands for "Registration, Evaluation and Authorisation of Chemicals" or "Registration, Evaluation and Authorisation of Chemicals". This European regulation no. 1906/2007 came into force on 1 June 2007, and applies across the board to provide a global framework for the activities of the European chemical industry. The aim of this regulation is to protect human health and the environment against the risks associated with chemical substances, and promotes the use of alternative methods (in vitro in particular) to assess the hazards of substances instead of animal testing.

Among the main provisions, registration (Title II) is built around the following 2 principles :

• no data, no market, with the burden of proof on industry
• one substance, one registration.

Thus, a regulatory dossier must be compiled and submitted to the authorities for any new import or manufacture (synthesis) of a substance in excess of one tonne per year by the legal entities concerned. Non-European entities can also register through an
Only Representative (OR).

This dossier contains a number of pieces of information :

• Individual and specific to each reporting company: uses, tonnages, industrial sites, chemical specifications, etc.
• Shared between all co-registrants of the same substance: physico-chemical, (eco)toxicological properties and information on the environmental fate of substances, the requirements of which are listed in Annexes VII to X of REACH. This hazard information will be useful to establish a Risk Assessment Report (RAR), required in the dossier from the threshold of 10 tonnes per year.

A data sharing system (Substance Information Exchange Forum, SIEF) is also in place, in return for a financial contribution (Letter of Access, LoA).
The system is governed by implementing regulation 2016/9 and by private law contracts between the co
registrants. The average cost of a registration dossier for the tonnage band has been estimated by the European Commission between 1 and 10 tonnes/year at 95k€ and 280k€ between 10 and 100 tonnes/year 1 , including the fees provided for in Regulation 340/2008.

Exceptions to registration are however provided for synthetic intermediates, recovered recovered substances (after removal from waste status), polymers, non chemically modified or dangerous natural substances, etc. These exemptions are either partial (less information to be These exemptions are either partial (less information to be submitted) or complete (no dossier to be registered).

REACH registration dossiers can then enter an evaluation process (Title VI), both in terms of the completeness of the information with regard to Annexes VI to X of REACh, and its quality/compliance. Other processes may be initiated successively or
independently :

• Authorisation (Title VII), for which a general prohibition of any activity with a substance is to be understood, with some exceptions
• Restriction (Title VIII), providing for specific and diverse provisions to limit uses, avoid impurities, etc.

The implementation of the registration process was progressive, with 3 deadlines in 2010, 2013 and 2018. Nevertheless, new registrations are still taking place to bring the manufacture/import of of new substances, or as a result of changes in supply chains.
supply chains.

For example, REACH registration has created an unprecedented global database, which is publicly available on the European Chemicals Agency (ECHA) website.