What is REACH?
REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals while enhancing the competitiveness of the EU chemicals industry.
REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals and requires all companies manufacturing or placing a substance (on their own, in mixtures or in articles) on the EU market in quantities greater than 1 t/year to register that substance with the European Chemicals Agency (ECHA).
- Registration: Substance assessment, preparation of a dossier and registration by industry
- Evaluation: Evaluation of registration dossiers by the European Chemicals Agency (ECHA); checking for quality and completeness
- Authorisation: Authorisation of Substances of Very High Concern (SVHC) for certain uses by the ECHA
- Restriction: Restriction of the manufacture, use or placing on the market of hazardous substances by the ECHA
For legal reasons, only companies with a legal entity in Europe are allowed to submit a registration under REACH; however, non-EU companies may submit REACH registration by appointing an Only Representative to register on their behalf, in which case their importers will be regarded as downstream users and do not need to do registrations.
REACH Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02006R1907-20200428&qid=1593863162855&from=en
What Must be Registered?
Companies are affected by REACH if they manufacture or import a chemical substance in volumes ≥ 1 tonne per year.
- Substances on their own (single substances and no mixtures)
- Substances as components of mixtures
- Substances in articles (if these are intended to be released under normal or reasonably foreseeable conditions of use (e.g. scented candles, perfumed textiles).
- Substances as a component of articles with properties of very high concern (SVHC) that are named on the Authorisation List (REACH Annex XIV) and contained in products at a concentration of ≥ 0.1 %.
Note: Under REACH, only chemical substances, NOT products/product names are registered.
Obligations under REACH
Obligations in the supply chain
| Role | Obligations | Potential Obligations |
|---|---|---|
| Manufacturer and importer of substances, mixtures, articles | Pre-registration Registration Sharing information with customers Information archiving |
Application for authorisation Compliance with the restrictions Notification of hazardous substances in the classification and labelling inventory Chemical Safety Assessment |
| Importer of articles | – | Notification of the SVHC* Sharing information about SVHC* Compliance with the restrictions Information archiving |
| Downstream Users | Check of eSDS Implementing risk management measures Information archiving |
Feedback to supplier about the use Preparation of the SDS Sharing information with customers |
| Traders | Information archiving | Sharing information with customers (e.g. SDS) Sharing information with suppliers (e.g. use, substance release) |
Timeline & Transition Periods
June 1, 2007
REACH came into forceJune 1, 2008
Registration of non phase-in substances (new chemicals) starts & Pre-registration of phase-in substances (existing substances already on the market) startsNovember 30, 2008
Pre-registration for phase-in substances endsDecember 1, 2008
Registration for existing substances (that have not been pre-registered) startsJanuary 1, 2009
ECHA publishes list of pre-registered substancesSIEFs are formed
December 1, 2010
Deadline for pre-registered phase-in substances registration when supplied at:- phase-in substances > 1000 tpa
- R50/53 > 100 tpa
- CMR Categories 1 and 2 > 1 tpa