EU REACH Certification

Introduction to EU REACH Certification

REACH is the abbreviation of the EU Regulation REGULATION concerning the Registration, Evaluation, Authorization and Restriction of Chemicals, which was established by the EU and implemented on June 1, 2007.

This is a proposal for regulations concerning the safety of chemical production, trade and use. The regulations are aimed at protecting human health and environmental safety, maintaining and improving the competitiveness of the chemical industry in the EU, and developing innovative capabilities for non-toxic and harmless compounds, preventing market fragmentation, increasing transparency in the use of chemicals and promoting non-animal experiments. To pursue the sustainable development of society and so on. The REACH Directive requires that chemicals imported and produced in Europe must be registered, assessed, authorized and restricted through a comprehensive set of procedures to better and more simply identify the chemical components to ensure environmental and human safety. The directive includes registration, evaluation, authorization and restriction. Every commodity must have a registry of chemical constituents and a description of how the manufacturer uses these chemicals and toxicity assessment reports. All information will be entered into an ongoing database managed by the European Chemicals Agency, a new European Union agency in Helsinki, Finland. The agency will assess each file and may take stricter measures if chemicals are found to have an impact on human health or the environment. Based on the assessment of several factors, chemicals may be banned or need to be approved before they can be used.

It is reported that, unlike the RoHS directive, REACH covers a much wider range of products and manufacturing processes in almost all industries, from mining to textile and apparel, light industry, electromechanical, etc. REACH requires manufacturers to register about 30,000 chemicals in each product -- and to measure their potential hazards to public health. REACH establishes the idea that society should not introduce new materials, products or technologies if their potential hazards are uncertain.

Mechanical and electrical products have always been one of the most important parts of Ningbo's foreign trade. As downstream users of the chemical industry, no mechanical and electrical enterprises trading with Europe can be exempted from the REACH system. The draft REACH regulation stipulates that producers and importers of marketable chemicals and other tangible products entering the EU have the following obligations:

(1) To collate and submit detailed reports (i.e. registration) 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. Material in an independent substance or product with a quantity greater than or equal to 1 ton/year/person;

2. Monomers or other substances existing in polymers in the form of monomeric units or chemically bound substances in upstream suppliers with unregistered content (weight ratio) of more than 2% and total amount of more than 1 ton/year/person;

3. Substances in articles that are more than 1 ton/year/person and intentionally released under normal or reasonably predictable use conditions;

4. Total quantity > 1 ton/year/person. The Chemicals Bureau has reason to suspect that it will release substances from articles which are harmful to human beings or the environment. The Chemicals Bureau may request registration.

In REACH regulations, exemptions from registered substances include:

1. 1 ton/year/human substance

2. Radioactive substances

3. Without any treatment or processing under Customs supervision: (1) temporary storage for re-export, or in bonded areas or warehouses; or (2) transit

4. Non-separated intermediates

5. Means of transport for dangerous substances

6. Waste

7. Member States are exempted from defense

8. Medical or veterinary drugs

9. Additives, food condiments and animal nutrients in food or feed

10. Substances in Annex IV (known low risk)

11. Substances in Annex V

12. Re-import of registered substances themselves or substances in products

13. Recovery process of registered substances themselves, products or substances in Articles

14. Polymers (polymer itself) (except for monomers or chemically bound substances in polymers in the form of monomeric units or compounds whose unregistered content [weight ratio] (> 2%) in upstream suppliers and total amount (> 1 ton/year)

15. Chemicals (PPORD) for products or R&D only (5+5/10)

16. Active ingredients and excipients (co-formulas) used only in plant protection products (considered registered)

17. Active ingredients used only in biological killers (considered registered)

18. Substances that have been declared for new chemicals (deemed registered) in accordance with 79/831/EEC Directive

(2) Assess the safety factor of each chemical substance contained in the product ("Chemical Safety Assessment").

The contents of the assessment are as follows:

1. Archives evaluation is to verify the integrity and consistency of registration files submitted by enterprises.

2. Material assessment is to verify whether the substance needs further information from the enterprise.

3. Assessment mainly includes Dossier Evaluation and Material Evaluation.

Dossier Evaluation includes:

Within three weeks after registration, the European Chemicals Administration shall provide the registration data and integrity inspection report of the registrant to the competent authorities of Member States. But as of the date of registration in stages