REACH is the Regulation(EC)No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization, and Reatriction of Chemicals. REACH Regulation (EC) No 1907/2006 It entered into force on 1 June 2007.

What are the Key provisions of REACH Regulation?

◆ Regulation: Substance manufactured/imported over 1 ton per year need to be registered with the European Chemical Agency (ECHA) by EU manufacturers and imports; non-EU companies have to rely on EU REACH Only Representative 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.

◆ Authorization: Listed Substance of Very High Concern(SVHC) in Annex XIV will not be allowed to be used, placed on the market or imported into the EU after a data to be set unless the company is granted an authorization.

◆ 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) need 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.

◆ Any producter 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 article do not contain the substance which 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 articles containing the chemicals as Substance 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 by a consumer any supplier of an article containing the chemicals as Substance 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 concerntration 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: As yet,  SVHCs have been included in the Candidate List. Inclusion on the list imposes new information requirements on suppliers of preparations and articles containing the substances. The list of chemicals is extensive can be found at http://echa.europa.eu/candidate-list-table

◆ Restriction of Chemicals

What substances are exempt from REACH Regulation?

◆ Radioactive substances

◆ Substances under customs supervision

◆ The transport of substances

◆ Non-isolated intermediates

◆ Waste, re-imported goods

◆ Annex IV: e.g.: low hazardous substances

◆ such as water, starch, vitamin A, glucose…

◆ Annex V: e.g.: by-products, hydrates, naturally existing substances(oxygen, mineralores)…

What is SVHC?

According to the article 57 of REACH Regulation, Substance that are one of the following can be regarded as Substance of Very High Concern (SVHC):

(a) carcinogenic, mutagenic or toxic to reproduction(CMRs);

(b) persistent, bio-accumulative and toxic (PBTs);

(c) very persistent and bio-accumlative (vPvBs);

(d) seriously and/ or irreversibly damaging the environment or human health, as substance damaging the hormone system;

SVHCs might have been introduced to various consumer products due to the complexities of supply chain and manufacturing process and therefore companies should comply with the requirements of REACH relating to the presence of SVHC in their products and screen their products for SVHCs to ensure that they are safe for their consumers.

More importantly, companies shall monitor the update of SVHC candidate list or authorization list closely. Every time when a SVHC candidate list or authorization list is updated, you shall re-evaluate your products and your obligations under REACH.

How can I achieve SVHC compliance in accordance with REACH regulation?

Firstly, you need to identify all possible hazardous substances in your products and find out which list they belong to (SVHC candidate list or Restriction listor Authorization list?). You may do so by carrying out SVHC testing by yourself or asking your suppliers to carry out testing.

At PTS Testing Service, we offer REACH SVHC testing for a variety of product sectors including footwear, leather goods, accessories, garments and apparel, upholstery, toys, homeware and much more . . .