The Regulation (EC) No 1907/2006 refers to the registration, evaluation, authorisation and restriction of chemical substances and preparations. It is known by the abbreviated name REACH Regulation, and came into force on 1 June 2007. This EU-wide regulation aims to regulate the manufacture, placing on the market and use of chemical substances and mixtures. The aim is to protect human health and the environment. The implementation and monitoring of this Regulation is the responsibility of the ECHA, the European Chemicals Agency.
In the Gabinete Técnico Farmacéutico M. Camps, we often discuss the European regulations affecting cosmetic products or chemicals used in cosmetics. In the Rapex reports, which we post every week on social media, we provide information about these regulations. And the REACH Regulation, is one of the regulatory texts used by the EU to assess product safety.
At present, the REACH Regulation is back in the news due to a matter of deadlines. 31 May 2017 marks the deadline for the pre-registration of substances. And those that are submitted must be recorded as at 31 May 2018. This second deadline is the cut-off date for registering substances with the EU that are manufactured or imported in quantities exceeding one tonne.
What steps need to be taken to register a substance under REACH?
You need to apply for the Registration File in the REACH Register. This notification comprises two documents: firstly, a Technical File, which provides information on the classification of substances and their uses. The greater the tonnage manufactured or imported, the more information must be provided about the substance.
And on the other hand, a Chemical Safety Report, which applies whenever more than 10 tonnes of a chemical substance are manufactured or imported. The first thing that must be submitted is a hazard assessment. If the substance is classified in accordance with the Regulation (EC) No 1272/2008 of the European Parliament and of the Council, regarding the classification, labelling and packaging of substances and mixtures; in addition, the following must be submitted: an exposure assessment and a risk characterisation.
Important: Please note that substances must be submitted using the specified format IUCLID.
The REACH Regulation: a regulatory framework for chemicals
The name REACH is an abbreviation of Registration, Evaluation, Authorisation and Restriction of Chemical Substances and Mixtures. And to achieve this objective, the regulations set out specific requirements for each of these four processes.
- Registration: Any substance manufactured or imported in quantities of 1 metric tonne or more per year must be registered.
- Assessment: It is necessary to analyse the risks to health and the environment in accordance with the established criteria.
- Authorisation: Companies must apply for authorisation to use all substances classified as substances of very high concern under the REACH Regulation.
- Restriction: It is essential to know which substances are banned or restricted, as they pose an unacceptable risk to human health and the environment.