澳博国际官网 Regulatory Service
澳博国际官网 Regulatory Service

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澳博国际官网 is the Regulation (EC) NO 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals, which came into force on 1 June 2007 and applied on 1 June 2008. It becomes a harmonised regulation concerning preventative administration on all chemicals to be placed on the EU market superseding more than 40 directives and regulations for chemical management. The implementation of the regulation materially impacts the export to the European Union especially that of chemicals, electromechanical products, textiles, printing and dyeing, rubber, plastics, toys and furniture, etc.

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Registration: Substance manufactured/imported over 1 tonne per year needs to be registered with the European Chemical Agency (ECHA) by EU manufacturers and importers; non-EU companies have to rely on EU 澳博国际官网 Only Representative (OR) to submit registration on their behalf.

Evaluation: Registration dossiers submitted will be examined by ECHA in terms of completeness and data requirements. ECHA will also assess a substance of concern for its environment/public health impact.

Authorisation: Listed Substance of Very High Concern (澳博国际官网) (Click here to learn more about 澳博国际官网) in Annex XIV will not be allowed to be used, placed on the market or imported into the EU after data to be set unless the company is granted an authorisation.

Restriction: Annex XVII of the 澳博国际官网 Regulation contains the list of all restricted substances, specifying which uses are restricted or even banned.

Communication in the supply chain: Information about the safe use of chemicals (risk management measures) needs to be communicated up and down the supply chain in the format of Safety Data Sheets or Chemical Safety Report.

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澳博国际官网 applies to substances manufactured or imported into the EU in quantities of 1 tonne per year or more. It covers substances on their own, in a preparation or in an article manufactured, imported, placed on the market or used.

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Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if both the following conditions are met:

(a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year; and

(b) the substance is intended to be released under normal or reasonably foreseeable conditions of use.

If the articles do not contain the substance which is intended to be released under normal or reasonably foreseeable conditions of use, that the articles shall fulfill the following regulatory obligations:

1) Any supplier of an article containing the chemicals as Substances of Very High Concern (澳博国际官网s) and the concentration above 0.1% weight by weight shall provide the recipient of the article with sufficient information, available to the supplier, to allow safe use of the article including, as a minimum, the name of that substance.

2) On request of a consumer, any supplier of an article containing the chemicals as Substances of Very High Concern (澳博国际官网s) and the concentration above 0.1% weight by weight shall provide the relevant information, free of charge, within 45 days of receipt of the request.

 3) Any producer or importer of articles contain the chemicals as Substance of Very High Concern (澳博国际官网s) shall notify the Agency, if both the following conditions are met: (a) the substance is present in those articles in quantities totalling over 1 tonne per producer or importer per year; (b) the substance is present in those articles above a concentration of 0.1% weight by weight(w/w).

4) Any producer or importer of articles should supply SDS/MSDS to their downstream users when the 澳博国际官网 concerned is produced or imported at or above 0.1% w/w in a mixture or preparation;

Remark: There are 235 澳博国际官网s in the . While new inclusion of 澳博国际官网 in the list imposes requirements on suppliers of preparations and articles containing the substances.

Restriction of Chemicals ( )

This list of restricted substances is Annex XVII to 澳博国际官网 known as Restrictions on the Manufacture, Placing on the Market and Use of Certain Dangerous Substances, Preparations and Articles. It creates important obligations for articles besides that for 澳博国际官网s. ECHA will include the substances in the Annex XIV (Authorisation List) into Annex XVII and give the maximum exemption to restrict its manufacture and import on a Community-wide basis when the risks resulting from their use can be properly controlled and suitable alternatives are available, which are economically and technically viable.

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If your product is a chemical product, you need to ensure that every substance in it has been registered under EU 澳博国际官网 if the volume of that substance exceeds 1t/y. The best way to show compliance is to obtain a 澳博国际官网 registration number issued by the European Chemicals Agency (ECHA).

If your product is an article (i.e., clothes, electrical appliances), you most likely need to check if your product contains any substance of very high concern(澳博国际官网) and any substances on 澳博国际官网 annex XVII restricted substance list. Most of buyers probably do not want to buy any article containing a 澳博国际官网 more than 0.1%w/w or any article that does not meet 澳博国际官网 restriction conditions.

Read more about 澳博国际官网 or .

CIRS botiantang launched the following one-stop 澳博国际官网 compliance services in response to the relevant requirements of the EU 澳博国际官网 regulations, eliminating trade barriers brought by 澳博国际官网 regulations, clarifying the responsibilities and obligations of upstream and downstream parties in the supply chain, significantly reducing response costs and accelerating the trade process. And we strive to improve the compliance awareness of all parties in the trade and achieve a healthy and sustainable trade process through professional services.

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If you have any needs or questions, please contact us at [email protected].

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