Registration is the core of REACH regulations, with an estimated 80% of all substances requiring registration.
Mandatory: Producers/importers of substances with an annual production capacity greater than one ton
Registered entity: manufacturer/importer of chemicals within the EU
Management department: European CHemicals Administration (ECHA)
Substances that need to be registered:
More than 30000 existing substances, 4300 new substances, and new substances to be listed after the regulations come into effect
Registration principles:
(1) No registration, no market
(2) One substance, one registration (OSOR)
Information required for registration:
1. Registration documents (registration files)
2. Material properties
3. Manufacturers or importers of substances
4. Production or import volume of substances
5. Classification and labeling of substances
6. Substance Uses
7. Guidelines for the safe use of substances
Purposes of evaluation:
(1) Review compliance with regulatory requirements
(2) Review whether there are risks of harm to human health and the environment
(3) Maintain a minimum level of animal testing
Evaluation content: document evaluation and material evaluation
(1) Document Evaluation: Conducted by the Authority to review whether the information provided by the registrant meets regulatory requirements and decide whether further testing and evaluation are required. At this stage, all proposals for animal testing will also be carefully reviewed to limit them to an absolute minimum.
(2) Material assessment: For selected substances that are suspected to pose risks to human health and the environment, a material assessment is required. This work is shared by the governments of each member country, and recommendations are made on what actions should be taken under authorization or restriction procedures.
Authorization: Only substances of high concern require authorization
Procedure: Enterprise application, review and evaluation by the Chemical Administration, authorization by the European Commission for specific uses of substances
Target: Approximately 1500 high concern substances require authorization, including:(br)
(1) CMR substances: carcinogens, mutagens, substances toxic to the reproductive system
(2) PBTs substances: persistent, bioaccumulative, and toxic substances
(3) VPvB substances: high persistence and very bioaccumulation substances
(4) Substances that are equivalent to the above three categories and have serious and irreversible effects on humans and the environment, such as certain endocrine disruptors
Authorization application requirements: When there are alternative substances, there must be an alternative plan; When there are no substitute substances, there should be a research and development plan
Restriction:
Any substances, whether contained in its own products or products, must be restricted within the EU as long as its use poses unacceptable risks to human health and the environment.
Restriction type:
(1) Restricted use in certain products
(2) Restrict consumer use
(3) Restrict all uses (i.e. completely prohibit)
The purpose of the SIEF forum is to avoid repeated experiments, especially animal experiments, through information exchange.
On the Substance Information Exchange Forum (SIEF), you can achieve:
(1) 20 months after the regulations come into effect, check whether there have been any experimental studies
(2) Within 2 weeks, the holder of the test results shall issue a certificate to the searcher
(3) Negotiate cost sharing
(4) The holder of the test results shall provide the test results within 2 weeks after receiving the fees
(5) If there is no experiment, the participants will negotiate the trial bearer and cost sharing
(6) If the holder of the experimental results refuses to provide it, the management bureau shall provide the research abstract in a timely manner, and the holder of the results has the right to request that the expenses be shared equally
Before conducting vertebrate experiments, participants in SIEF should query the database through SIEF to determine whether relevant studies have been conducted. If a relevant research result can be obtained within the SIEF, participants in the SIEF who need to conduct vertebrate experiments request to obtain the research result within a specified period of 2 months.