If you are a company that works with hazardous substances, you are most likely familiar with REACH. REACH stems from the European Regulation on Registration, Evaluation, Restriction Measures and Authorization of chemicals, and came into force on June 1, 2007. The REACH Regulation is very extensive: including all annexes around 1350 pages. In the Netherlands, the regulation is set out where necessary in Titles 9.2 and 9.3 of the Environmental Management Act (WM).
In this blog I discuss the following three topics: the registration requirement under REACH, the amended regulation and the REACH Agency.
The registration requirement under REACH
Importers and downstream users of hazardous products must register information about these products. The main purpose of this obligation is to provide a high level of protection for people and the environment. Each country has a designated body where the product is registered. In each country where a product is marketed, the product must be registered. So if a product is marketed in both the Netherlands and Belgium, the product must be registered in both countries. In the Netherlands, the product is registered with the Nationaal Vergiftigingen Informatie Centrum (NVIC) of the University Medical Center in Utrecht.
As a result of the entry into force of EU Regulation 2017/542, Annex VIII has been added to EU Regulation 1272/2008. Annex VIII contains information on: (1) what product information must be submitted, (2) the electronic format by which the information must be submitted, and (3) the Unique Formula Identification (UFI) which must be included on the label of a hazardous product. For example, a distributor may not market a mixture if the NVIC has not received an Annex VIII submission or if the NVIC has received an incomplete submission from the supplier.
The Annex takes effect in stages. In the first stage, the rules of and format for changes to existing or for new product notifications of consumer and professional products change. As a result, the information will no longer have to be submitted directly to the NVIC, but as of January 1, 2021, must be submitted via an online portal of the European Chemicals Agency (ECHA). ECHA will take care of distributing the information to the appropriate member states. Industrial products will follow in the second stage on January 1, 2024, and finally on January 1, 2025, all existing product notifications will also have to be resubmitted according to the new rules.
The REACH Agency
The REACH Regulation requires member states in Article 121 to designate a competent authority as responsible for carrying out the tasks assigned to the competent authority in the regulation and for cooperating with the European Commission and the European Chemicals Agency. In the Netherlands, under Article 9.3.2 WM, the Minister of Housing, Spatial Planning and the Environment (now the Minister of Infrastructure and Water Management) is the competent authority. To carry out the tasks assigned to the Minister, the REACH Office was established. According to Section 2 of the Decree establishing the REACH Agency, the agency is located at the National Institute for Public Health and the Environment (RIVM) and is part of the Substances Expertise Center (SEC). The REACH Agency answers practical questions about REACH, such as what information the product identification of mixture ingredients should contain.
It is important that you pay close attention to whether you are acting in accordance with the provisions of the REACH Regulation. Violation of the provisions of the REACH Regulation can be punished with imprisonment for up to 6 years or a fifth category fine (€ 82.000,-).
Want to know more?
Do you doubt whether you are acting in accordance with the REACH Regulation? Or do you have other legal questions? Please feel free to contact one of our lawyers.