The European Union has set itself the objective 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 tonne or more of chemicals (per year), you must register it in the REACH database. It applies to a wide variety of products, from toys to textiles and electronic devices. Only registered substances can 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 chemical products (REACH), establishes a European Chemical Products Agency. 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 Directives 91 / 155 / CEE of the Commission, 93. / 67 / CEE, 93/105 / CE and 2000/21 / CE. The regulation came into force on June 1, 2007. Projects that implement REACH are called PIRs.
The acronym REACH comes from the first letters of the main actions related to the regulation: Registration, Evaluation, Authorization and Restriction of Chemical Substances. In summary, REACH establishes the procedures for collecting and evaluating information on the properties and hazards of substances and their mixtures.
Where are the REACH substances?
The REACH Regulation affects most companies in the European Economic Area (EEA). Includes chemicals observed in:
* paints, varnishes,
* clothing and textiles,
* electronics devices,
* Cleaning products,
* plastic products,
* Construction 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 substances and their mixtures, transported by rail, road, inland waterways, sea or air transport,
* used for research and development,
* radioactive (Council Directive 96/29 / Euratom),
* obtained from nature (if they are not dangerous and have not been chemically modified),
* Medical products,
* Cosmetic products,
Who must register in the REACH database?
We mention 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:
* a manufacturer, which means that it produces chemicals on the territory of the Community,
* an importer, which means that you buy (outside the EU) individual chemicals and their mixtures or finished products containing these substances (furniture, clothing, plastic products, etc.) to resell the products,
* a distributor, which means that it stores and markets chemicals or chemical mixtures,
* a downstream user: means that you use chemicals and their mixtures in your 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. REACH obligations do not apply to non-EU manufacturers, but they do apply to their representatives. The downstream user of chemicals must take risk management measures and communicate safety information to suppliers and customers. There is no obligation to register. Distributors provide information in both directions throughout the supply chain (manufacturers and customers).
You can familiarize yourself with all your obligations using the Navigator tool.
How does REACH work?
The regulation establishes rules related to:
* mandatory registration if the company intends to import or manufacture one ton or more per year of a particular chemical. To register substances, a company must cooperate with others who register the same substance. In other words, manufacturers and importers of the same substance must jointly file a registration,
* evaluation of the European Chemicals Agency (ECHA). Examine the information in the registration files, as well as the test proposals, in terms of their need,
* authorization of certain high-risk substances. These chemicals must be replaced by safer ones. alternatives,
import or production restrictions, which may limit or prohibit substances if they pose a significant risk to health or the environment.
* Information on the relevant substances and 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 term for the payment of the fee and its amount depends on the type of presentation. For example, small and medium-sized enterprises (SMEs) receive reduced rates. The registration fee can reach millions of euros. However, the cost does not include tests such as HPLC, MS, IR, and NMR. Read about payment on the ECHA website.
Registration in the system may take several months.