REACH - Registration, Evaluation, Authorisation, Restriction of Chemicals
REACH (Registration, Evaluation, Authorization & Restriction of CHemicals) is a European chemical regulation for the registration, evaluation, approval and restriction of chemical substances. REACH Regulation (EC) No. 1907/2006 has been in force since June 1, 2007 to ensure protection for people and the environment.
REACH is based on the principle that manufacturers, importers and users are equally responsible for their chemicals. You must ensure that chemicals that they manufacture and place on the market are used safely. It is not allowed to manufacture, import or acquire a non (pre) registered substance in the EU!
The REACH regulation is one of the strictest chemicals laws in the world.
The story before REACH ...
REACH builds on the experience of previous chemical law. According to old law, the authorities had to check the safety of chemicals. No systematic information was available on most chemicals, namely those that were on the European market before 1981. Manufacturers were only required to provide missing information if a substance assessment by the authorities showed gaps in information or indicated that there was a risk to the environment or health. The process turned out to be slow and cumbersome. REACH should remedy this situation. Manufacturers and importers of chemicals now have to submit data with the mandatory registration and assess the risks posed by the substances themselves. The rule is: “no data - no market”. This means that chemicals cannot be placed on the market without registration. The tasks of the authorities are to support the actors, check the registrations and regulate substances with particularly worrying properties or substances that pose a risk to people or the environment. REACH also addressed other problems. There is now a right for consumers to get information about chemicals in products. The transfer of data within the supply chain is regulated and the substitution of substances of very high concern is encouraged. The approval process creates another way to regulate chemicals.
REACH is not only one of the most modern and at the same time also the strictest chemical laws, it is also a very detailed set of rules.
The aim of the REACH regulation is the systematic recording of all substances and mixtures of substances manufactured, imported and placed on the European market as well as their evaluation with regard to their hazard potential and the decision on appropriate risk management measures.
Registration of basic information
All chemical substances that are manufactured or imported in quantities of more than one ton per year are affected. As a registration company, you must submit information to the European Chemicals Agency (EChA) in Helsinki. There, these data are stored in a central database on the Internet. Experts expect such registration to be sufficient for around 80 percent of the substances in question.
Assessment of the information collected
The agency will evaluate the data submitted on substances that are manufactured in quantities of more than 100 tons per year or that are of particular concern, for example, have carcinogenic properties. Because of the large number of substances, this assessment is based on a tiered concept. Note: The obligation to label according to the CLP regulation is independent of this.
Carcinogenic, mutagenic or toxic substances for reproduction as well as certain persistent organic pollutants may only be used if they are expressly approved for the respective area of application. The European Chemicals Agency continuously publishes recommendations on the aforementioned substances of concern, which are to be subject to an authorization process. In addition, as before, there is the option of restricting the use of these substances instead.
Annex XIII to the REACH Regulation sets criteria for substances that are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB).
Under REACH, a PBT/vPvB assessment is required for all substances for which a chemical safety assessment is carried out. A chemical safety assessment is required for substances manufactured or imported in amounts of 10 tonnes or more per year, unless exemptions apply.
All biocidal active substances have to undergo a formal PBT assessment. You can see the status of biocides assessments on the Biocidal Active Substances page.
The PBT Expert Group supports Member States in their assessments. The substances undergoing a PBT/vPvB assessment under REACH or the Biocidal Products Regulation that have been brought for discussion to ECHA’s PBT Expert Group are included in the PBT assessment list.
The PBT/vPvB concern
Substances that persist for long periods of time in the environment and have a high potential to accumulate in biota are of specific concern because their long-term effects are rarely predictable. Once they have entered the environment, exposure to these substances is very difficult to reverse, even if emissions are stopped.
Protection of pristine remote areas from PBT/vPvB substances is particularly difficult, as these substances do not degrade near emission sources but may be gradually transported into remote areas. A ‘safe’ concentration in the environment cannot be established using the methods currently available.
A particular concern with vPvB substances is that even if no adverse effects can be demonstrated under laboratory testing conditions, long-term effects might be possible, as high but unpredictable levels may be reached in humans or the environment over extended time periods.
As a company, we see it as our duty to meet these requirements.
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