What is the scope of REACH regulation registration? REACH is exempt from registration of substances. REACH regulations stipulate that manufacturers and importers of chemicals and other tangible products entering the EU market have the following obligations:
(1) REACH registration
(Collate and submit a detailed report including the test data of each chemical substance contained in the product.) In REACH regulations, the scope of registration of chemical substances mainly includes:
1. Independent substances or substances in preparations with quantity ≥ 1 ton/year/person;
2. Unregistered monomers or other substances in polymer in the form of monomeric units or chemical bound substances in upstream suppliers with content (weight ratio) ≥ 2% and total amount ≥ 1 ton/year/person;
3. Substance in articles with total amount>1 ton/year/person and which will be released intentionally under normal or reasonably foreseeable use;
4. If the total amount is more than 1 ton/year/person, the Chemical Bureau has reason to suspect that the substances in the articles will be released from the articles and this release is harmful to human body or the environment, the Chemical Bureau can request registration.
In REACH regulation, substances exempted from registration include:
1. 1 ton/year/person of substance
2. Radioactive substances
3. Without any treatment or processing under the supervision of the customs: (1) temporarily stored for re-export, or in the bonded area or bonded warehouse; Or (2) transit
4. Non-separated intermediate
5. Means of transport for dangerous substances
6. Waste
7. Exemptions of member states due to national defense
8. Medicine or veterinary medicine
9. Additives, food flavoring and animal nutrition in food or feed
10. Substances in Annex IV (known low risk)
11. Substances in Annex V
12. Re-import of registered substances or substances in products
13. When the registered substances themselves, products or substances in articles are reprocessed (recovery process)
14. Polymer (polymer itself) (except for monomers or other substances in polymer in the form of monomeric units or chemical bound substances that are not registered in upstream suppliers with content [weight ratio] ≥ 2% and total amount ≥ 1 ton/year)
15. Chemical substances (PPORD) only used for products or research and development (5+5/10 years)
16. Active ingredients and excipients only used in plant protection products (considered as registered)
17. Active ingredients only used in biocides (considered as registered)
18. According to Directive 79/831/EEC, substances that have been declared as new chemical substances (considered as registered)
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