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 since June 1, 2007. REGULATION concerning the Registration, Evaluation, Authorization and Restriction of Chemicals, which was established by the EU and implemented since June 1, 2007, is a regulatory system for chemicals.

It is a proposed regulation concerning the production, trade, and safety of use of chemicals, which aims to protect human health and environmental safety, maintain and improve the competitiveness of the EU chemical industry, as well as the innovative ability to develop non-toxic and non-hazardous compounds, prevent market fragmentation, increase the transparency of chemical use, promote non-animal experimentation, and pursue sustainable social development, etc. The REACH Directive requires that all chemicals imported and produced in Europe must be registered, evaluated, and restricted by the EU. The REACH Directive requires that all chemicals imported and produced in Europe must be registered, evaluated, authorized and restricted through a comprehensive set of procedures to better and more simply identify the components of chemicals for the purpose of ensuring environmental and human safety. The main elements of the Directive are registration, evaluation, authorization, and restriction. Any commodity must have a registration file that lists the chemical ingredients and describes how the manufacturer uses them, as well as a toxicity assessment report. All the information will be entered into a database under construction and managed by a new EU agency, the European Chemicals Agency, based in Helsinki, Finland. The agency will evaluate each file, and if chemicals are found to have an impact on human health or the environment, they may take more stringent measures. Depending on the results of the assessment of several factors, chemicals may be banned or need to be approved before they can be used.

According to the report, unlike the RoHS directive, REACH covers a much wider scope, and in fact it will affect products and manufacturing processes in almost all industries, from mining to textiles and apparel, light industry, electromechanics, etc. REACH requires manufacturers to register every chemical component in their products - about 30,000 in total - and to measure its potential harm to REACH establishes the idea that society should not introduce new materials, products or technologies if their potential hazards are not known with certainty.  　Electrical and mechanical products have always been one of the most important foreign trade in Ningbo area. As a downstream user of chemical industry, none of the electromechanical trade with European

The draft REACH regulation imposes the following obligations on producers and importers of chemicals and other tangible products entering the EU market:

(i) to compile and submit a detailed report including test data for each chemical substance contained in the product (i.e., "registration").  　The scope of registration of chemical substances under REACH mainly includes.

1. substances in independently existing substances or preparations in quantities ≥ 1 ton/year/person;

2. unregistered in the upstream supplier content (weight ratio) ≥ 2% and the total amount of ≥ 1 ton / year / person in the form of monomeric units (monomericunits) or compounds (chemically bound substances) in the polymer monomer or other substances;

3. substances in articles (substances in articles) that are intentionally released in a total amount >1 ton/year/person and in a normal or reasonably foreseeable state of use;

4. substances in articles where the total amount is >1 ton/year/person and the Chemicals Agency has reason to suspect that there will be a release from the article and such release is harmful to humans or the environment, the Chemicals Agency may require registration.

REACH regulation, exempted from registration substances are.

1. 1 ton/year/person

2. radioactive substances

3. under customs supervision without any treatment or processing: (1) temporarily stored for re-export, or in bonded areas or bonded warehouses; or (2) in transit

4 non-isolated intermediates

5 transport means of transport of hazardous substances

6. waste

7 Member States exempted for reasons of national defense

8 pharmaceutical or veterinary drugs

9 additives in food or feed, food flavoring and animal nutrients

10 substances in Annex IV (known to be of very low risk)

11 substances in Annex V

12 re-imported substances in the registered substances themselves or products

13 registered substances themselves, products or articles in the substance when reprocessed (recovery process)

14. polymers (polymers themselves) (except for monomeric units (monomericunits) or compounds (chemically bound substances) in the form of monomers or other substances present in polymers that are not registered in the upstream suppliers with a content [weight ratio] ≥ 2% and a total of ≥ 1 ton/year)

15. chemical substances used only in products or R&D (PPORD) (5+5/10 years)

16. only for use in plant protection products in the form of active ingredients and excipients (co-formulants) (deemed to be registered)

17. only for biocides in the active ingredient (considered registered)

18. According to Directive 79/831/EEC, new chemical substances have been declared (deemed to have been registered)

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

The contents of the assessment are.

1,File assessment is to verify the completeness and consistency of the registration dossier submitted by the company.

2, substance assessment is to verify whether the substance requires further information from the company.

3, the assessment mainly includes file evaluation (Dossier Evaluation) and material evaluation (Substance Evaluation).  　File evaluation (Dossier Evaluation) includes.

--. ECHA shall provide the registrant's registration data and completeness check report to the competent authorities of the Member State within 3 weeks after registration. However, the registration dossier received within 2 months before the deadline for phased registration requires 3 months for review;

--. Non-phased registered substances, as well as phased registered substances past the registration deadline, are prohibited from production, sale for use and import in EU countries until the audit is passed (Member State competent authorities review the technical dossier: assess whether the registered technical documents comply with the provisions of the regulations and check the animal testing program to avoid unnecessary animal testing);

--. EU member states review the submitted draft tests and draft the relevant resolution. The resolution reads as follows:

(1) agree to conduct the experiments and submit a summary of the experimental results and constructive analysis of the study methods within the deadline (specified in Annex I).

(2) The resolution is the same as a, but requires that the experiments be conducted under the revised test conditions.

(3) Resolution as a, b, or d, but requesting one or more additional experiments when the submitted experimental objectives are inconsistent with the Annex requirements.

(4) The proposal to reject the experiment.

(5) Resolution with a, b or c, if several registrants submit the same experimental proposal, the Authority within 90 days to coordinate their agreement to find a test to represent the whole.

(6) consent to the experiment should be 45 days of public notice period.

The substance evaluation (Substance Evaluation) includes.

-. Authority to provide member countries with criteria for evaluating priority substances;

--. Providing a draft rolling plan for evaluation on December 1, 2011, and thereafter by February 28 of each year;

--. Member States to develop rolling plans for the assessment of substances selected from them that last for three years and to conduct assessments

--. the Authority posting the final assessment list online;

--. EU member states need to draft relevant resolutions within the specified period (180 days for new substances) to request further information materials.

(iii) Special authorizations for use are obtained according to the different nature of the chemicals.

The registration aspect of REACH Directive stipulates that only EU enterprises can be registered. If Chinese enterprises want to register in the EU, they have to choose an EU agency, and the actual cost includes agency fee, testing fee, registration fee, etc. It is generally estimated that the basic testing cost for each chemical substance costs about 85,000 Euros, and the testing cost for each new substance costs about 570,000 Euros. The increased cost of the chemical industry is bound to cause a chain reaction in the downstream industry. Make the original has been little profit margin of mechanical and electrical enterprises, the export situation is even less optimistic.

Inspection and quarantine institutions to remind the relevant production enterprises to pay great attention to the implementation of REACH regulations may bring great impact, production operators must establish the concept of green production, green marketing. Take countermeasures as early as possible to further track the progress of legislation, import, research and development, the use of non-toxic, low-toxic products, apply for registration of chemical products exported to Europe, strengthen testing, and timely reflect the technical barriers encountered