The European Union has set a goal of minimizing the significant negative effects on human health and the environment caused by the production and use of chemicals. One of the measures against such effects is the REACH regulation. If you operate in the EEA (European Economic Area) as a producer or importer of goods that together contain one ton or more of chemicals (per year), you are required to record this in the REACH database. It applies to a wide variety of goods, from toys to textiles and electronic devices. Only registered substances may be put into circulation and used.
Regulation (EC) No 1907/2006 of the European Parliament and of the Council introduces rules for the registration, evaluation, authorization, and restriction of chemicals (REACH), establishes a European Chemicals Agency. It amends Directive 1999/45/EC and repeals Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94, as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC, and 2000/21/EC. The regulation entered into force on June 1, 2007. Projects implementing REACH are called RIPs.
The acronym REACH comes from the first letters of the main actions concerning the regulation: Registration, Evaluation, Authorization, and Restriction of Chemicals. In short, REACH sets out the procedures for collecting and assessing information on the properties and hazards of substances and their mixtures.
Where are REACH substances?
The REACH Regulation affects most companies in the European Economic Area (EEA). It includes chemical substances observed in:
- paints, varnishes,
- clothing and textiles,
- electronic devices,
- cleaning products,
- plastic products,
- building materials,
- and others.
The regulation does not cover substances (always or in some cases):
- under customs control or in transit, temporarily stored in free zones or free warehouses,
- hazardous and their mixtures, transported by means of rail, road, inland waterway, sea, or air transport,
- used for research and development,
- radioactive (Council Directive 96/29/Euratom),
- obtained from nature (if they are not hazardous and have not been chemically modified),
- medical products,
Who should register in the REACH database?
We mentioned that Regulation (EC) No 1907/2006 applies to importers and producers who import or manufacture at least one ton of chemical substances per year. The regulation also applies to other business activities. The REACH regulation applies to your business if you are:
- a manufacturer, meaning that you produce chemicals within the territory of the Community,
- an importer, which means that you buy (outside the EU) individual chemical substances and their mixtures or finished products containing such substances (furniture, clothing, plastic products, and more) in order to resell the goods,
- a distributor, meaning that you store and place on the market chemicals or mixtures of chemicals,
- a downstream user: means that you use chemicals and their mixtures in their work or manufacturing process. The consumer is not a downstream user.
Each business activity is related to different responsibilities. The manufacturer and importer registering substances in the REACH database must also inform the European Chemicals Agency (ECHA) on how to use them safely. The obligations under REACH do not apply to non-EU manufacturers, but it does to their representatives. The downstream user of chemicals is required to take risk management measures and communicate safety information with suppliers and customers. There is no obligation to register. Distributors provide information in both directions along the supply chain (manufacturers and customers).
You can get familiar with all your obligations using the Navigator tool.
How does the REACH work?
The regulation establishes rules related to:
- mandatory registration if the company intends to import or manufacture a ton or more per year of a particular chemical substance. To register the substances, a company has to cooperate with other ones that register the same substance. In other words, manufacturers and importers of the same substance have to submit a registration jointly,
- evaluation by the European Chemicals Agency (ECHA). It examines information in the registration dossiers, as well as testing proposals, in terms of their necessity,
- authorization of certain high-risk substances. Such chemicals should be replaced with safer alternatives,
- import or production restrictions, which can limit or ban the substances if they pose a significant risk to health or the environment.
Information on substances and the relevant regulations can be found in the EUCLEF. The substances are also included in the REACH regulation.
There are fees applicable when registering a new chemical. The deadline for paying the fee and its amount depends on the type of submission. For example, small and medium-sized enterprises (SME) are granted reduced fees. The registration fee can reach millions of Euros. However, the cost does not include testing such as HPLC, MS, IR, and NMR. Read about the payment on the ECHA website.
Registration in the system may take up to several months.
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