Through this guide we will discover what the REACH regulation is, who must comply with it, which substances it affects and what its latest update implies.
What is the REACH Regulation?
The REACH regulation, also known as Regulation (EC) No. 1907/2006) is the European Union standard that establishes procedures to register, evaluate, authorize and restrict chemical substances and mixtures. Its main purpose is to protect health and the environment and promote the competitiveness of the sector within the community framework. In addition, it also promotes alternative methods to avoid animal testing.
REACH, which entered into force on June 1, 2007, establishes the establishment of a register when introducing chemical substances on the community market from 1 ton per year. The member countries of the EU are responsible for their compliance and for the evaluation of priority substances, in coordination with the ECHA or European Agency for Chemical Substances and Mixtures.
What is the ECHA?
REACH establishes the creation of ECHA, which is responsible for managing and supervising compliance with the regulation. This agency, based in Helsinki, acts as an interlocutor between the interested parties. It is also responsible for receiving and evaluating individual records. The scientific committees are responsible for evaluating whether the risks of substances can be managed, whether they should be banned or their use needs to be restricted.
Who Must Comply?
This regulation applies to almost all chemical substances (also those that we use on a daily basis), therefore it affects the majority of companies in the EU. In order to comply with the regulation, companies must identify the risks of the substances they manufacture or market and demonstrate to ECHA how to use them safely and communicate to users the measures they must take to avoid risks. Below we list the main profiles affected:
- Chemical manufacturers and distributors.
- Importers who buy chemical substances or mixtures outside the EU.
- Downstream users as most companies use chemicals (even without knowing it).
What substances does it affect?
The REACH regulation affects all chemical substances, except for the following:
- Radioactive.
- Waste.
- Supervised at customs.
- Non-isolated intermediates.
- Transport of dangerous substances.
On the other hand, there are exceptions in cases related to defence and there are certain uses that are exempt from part of the obligations, such as drug substances, cosmetics, medical devices, biocides, polymers, etc.
How does registration work?
The steps are the following:
- Companies must submit a registration application to ECHA for each individual substance or mixture that equals or exceeds one tonne per year.
- The request must include:
- A technical file depends on the volume and risk of the same.
- A chemical safety report or ISQ for substances that exceed 10 tons per year. It must include its uses and demonstrate that the risks are under control.
- One number is assigned per application, the results of which must be shared with other applicants.
How does it affect the safety data sheets (SDS)?
The Regulation establishes in its annex II a new model of safety data sheets (SDS). This is mandatory for all substances and mixtures since 2007, currently modified by Regulation 2020/878.
New update: Regulation 2020/878
Regulation (EU) No. 453/2010 modified Annex II of the REACH Regulation where the guide to correctly prepare safety data sheets is established. Currently, the new modification of the regulation was carried out in 2020 for its subsequent implementation in early 2021. This application of the regulation implies that all safety data sheets must be updated according to the new regulation in order to comply with REACH. You can consult more information in our article to know what the update consists of.
