What is REACH Regulation?
REACH 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.
What are the Key Provisions of REACH Regulation?
■ 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 REACH 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 (SVHC) (Click here to learn more about SVHC) 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 REACH 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.
What is the Scope of REACH Regulation?
REACH 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.
What are the Obligations of Articles under REACH Regulation?
■ 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;
(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 (SVHCs) 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 (SVHCs) 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 (SVHCs) 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 SVHC concerned is produced or imported at or above 0.1% w/w in a mixture or preparation;
Remark: There are 201 SVHCs in the Candidate List for Authorisation (SVHC List). While new inclusion of SVHC in the list imposes requirements on suppliers of preparations and articles containing the substances.
Restriction of Chemicals (REACH Annex XVII)
This list of restricted substances is Annex XVII to REACH 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 SVHCs. 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.
If your product is a chemical product, you need to ensure that every substance in it has been registered under EU REACH if the volume of that substance exceeds 1t/y. The best way to show compliance is to obtain a REACH 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(SVHC) and any substances on REACH annex XVII restricted substance list. Most of buyers probably do not want to buy any article containing a SVHC more than 0.1%w/w or any article that does not meet REACH restriction conditions.
If you want to comply with REACH requirements, you need to identify all possible substances of very high concern (SVHCs) and restricted substances in your products through testing services on your own or requiring your suppliers in the same supply chain for conformity. Please feel free to contact firstname.lastname@example.org or leave us a message if you would like to know more about REACH regulation or how to comply with it.
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