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. 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.
What are the Obligations of Articles under REACH Regulation?
◆ 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
Restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles in the Annex XVII of REACH Regulation means these restricted substance 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. If you want to compliance in accordance with REACH regulation, you need to identify all possible substance of very high concern (SVHC) and restricted substance in your products. You may do so by carrying out SVHC testing by yourself or asking your or asking your suppliers to carry out testing in the same supply chain. After knowing the existence and concentration of SVHC in your product, you could adopt the following measures to achieve REACH compliance.
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.
Then you could adopt the following measures to achieve REACH compliance if a SVHC is present in your products:
◆ SVHC Notification: Submit notification to European Chemical Agency (ECHA) if any SVHC on candidate listpresent in an article has a concentration above 0.1% (w/w) and the total amount of the SVHC exceeds 1 tonne per annum per producer or importer. The SVHC candidate list will be regularly updated from time to time.
◆ Communication Requirement: If any SVHC on candidate list is present in your product with a concentration above 0.1% (w/w), you are obliged to inform the recipients of the article along the supply chain about the chemical name(s) and how the article can be safely used. REACH further requires this information be made available within 45 days upon consumer request.;
◆ Restriction:Article suppliers not only need to comply with the requirements of SVHC, they also need to comply with the requirements of REACH Restriction. Some candidate SVHCs(for example, anthracene) are also on REACH restricted substances list (XVII of REACH). Involved parties must screen the REACH restriction list for the restriction most relevant to the products and ensure that the presence of restricted substances in products do not exceed threshold limits set by REACH;
◆ Authorization:Priority SVHCs on candidate list will be included in the Annex XIV of REACH (the "SVHC authorization List"). Those SVHCs will not be allowed to be used, placed on the market or imported into the EU after a date to be set unless the company is granted an authorization.
Note 1:ECHA states that in multi-component articles (e.g., a car, a television, etc) the 0.1% w/w limit applies to the average concentration of the entire article as produced or imported and not the individual components. However, some countries have their own interpretations.
Note 2:As more substances are included on SVHC candidate list, it becomes almost impossible to test all SVHCs in one product or one component. Screening before testing becomes very important.
What is the Notification of SVHC?
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 Restriction of Chemicals, which came into force on 1 June 2007. REACH Regulation specifies the responsibilities and obligations of chemicals substances and articles as the regulation with widest influence up to now.
According to REACH Regulation, Producers and importers have to notify to ECHA the substances listed on the Candidate list which are present in their articles, if both the following conditions are met:
(1) The substance is present in their relevant articles above a concentration of 0.1% weight by weight.
(2) The substance is present in these relevant articles in quantities totalling over one tonne per year. Companies have to notify no later than six months after the inclusion of the substance in the Candidate List.
Who need to be submit Notification?
◆ EU producers
◆ EU Importers
◆ Non-EU producers ( non-EU-manufacturers may do notification by appointing an EU-based Only Representative to notify on their behalf).
When to submit Notification?
◆ The substances being added in the Updated Candidate list before 1 December 2010 shall be notified before 1 June 2011;
◆ The substances being added in the Updated Candidate list after 1 December 2010 shall be notified within a 6-month period.
Why should submit Notification?
Products can only producted or imported in EU if they are complicant with REACH Regulation. The EU members have passed the rigorous measures of supervision and punishment under REACH Regulation. EU customs have rights to carry out the inspection of REACH compliance. Importers or producers will be punished by recall, fine, even the imprisonment for certain REACH-incompliant deeds.
Solution to REACH
Different types of products have different responsibilities in REACH. The first step to comply with REACH for industries which have their products produced or exported in the EU market is to analyze the type of the product and the responsibility to bear according to the REACH regulations, and have the chemical information passed down the supply chain. Meanwhile, it’s necessary to comply with the other EU Directive requirements in order to make the products fully comply with EU regulations.
PTS Testing Service makes deep study of REACH regulations, and is competent to provide customers with test services of Substances of Very High Concern (SVHC) and related consultation basing on the product’s features, and help solve the problems on production and selling of the product. Welcome to contact us for details.
PTS Testing Service SVHC REACH Testing Services
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What is SVHC REACH testing?
REACH testing is the testing of products manufactured, imported or retailed in the European Union against REACH Regulation. REACH Regulation is a European Union Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals. REACH aims to give industry greater knowledge about the chemicals it uses and ultimately this contributes to the prevention of health problems caused by exposure to chemicals.
Risks of non-compliance to your business
A large number of chemicals listed under REACH are substances of very high concern (SVHCs) due to their carcinogenic, mutagenic and toxic (to reproduction) properties. In addition to this, certain listed chemicals are categorised as PBTs (persistent, bioaccumulative, and toxic), and vPvBs (very persistent, very bioaccumulative) meaning that they have adverse effects on both human health and the environment.
Why carry out REACH testing and analysis on consumer products?
REACH covers all chemical substances manufactured in, or imported into the EU in quantities of 1 tonne per year or more. Registration under REACH is for substances only, however, the provisions of the regulation apply to the manufacture, placing on the market or use of substances on their own, in preparations or in articles. Following this the ECHA checks all registration dossiers for completeness and decides whether additional testing is necessary. For those chemical substances deemed to be of very high concern (SVHCs) an authorization and restriction process may be required.
Products may need to be tested at an independent laboratory in order to ensure REACH testing compliance. SVHC test screening and risk assessments are important tools in managing risk.
REACH Testing & Compliance – SVHC, Annex XVII
PTS Testing Service REACH Testing and Compliance Services
PTS Testing Service are here to help your business bring fit for purpose products to the market through REACH testing services. PTS Testing Service REACH testing covers a variety of testing and support services including:
REACH SVHC testing and screening service –PTS Testing Service test for the presence of the latest published SVHC list
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PTS Testing Service also offer a wide range of chemical testing services.
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SVHC Risk Matrix: Available to PTS Testing Service Members
PTS Testing Service Members can access the SVHC Risk Matrix, which guides members through the current SVHC’s. The SVHC Risk Matrix details the uses, applications, and the risk (high/medium or low) of substances being present in a number of different material categories.
REACH Regulations and Compliance Explained
REACH is a European Union Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals. REACH regulations aim to give industries greater knowledge about the chemicals they use and ultimately this contributes to the prevention of health problems caused by exposure to chemicals.
Reach Regulations, which came into force on 1st June 2007, were adopted because many thousands of chemicals are used within the EU, but the risks to human health and the environment from many of these are not widely known. REACH regulations intend to address this by making manufacturers, importers and distributors responsible for understanding and managing the risks associated with their use.
What is the scope of REACH Regulations and Compliance?
REACH covers all chemical substances manufactured in, or imported into the EU in quantities of 1 tonne per year or more. Registration under REACH is for substances only, however, the provisions of the regulation apply to the manufacture, placing on the market or use of substances on their own, in preparations or in articles.
What are the different stages of the REACH process?
Manufacturers or importers will need to register any substance they supply to the EU market above 1 tonne per year
The ECHA will carry out annual in-depth evaluations (i.e. assessments) of substances flagged as being of potential high risk (e.g. on the basis of information provided at registration)
The uses of substances of very high concern (SVHCs – go to our SVHC list and Reach regulations page for more information ), e.g. CMRs (carcinogens, mutagens, and toxic to reproduction), PBTs (persistent, bioaccumulative, and toxic), and vPvBs (very persistent, very bioaccumulative) will require authorisation
What is the candidate list?
The candidate list is a step in the REACH authorisation process. It is an SVHC list nominated by the European Commission or by the member states and decided upon by the ECHA after public consultation. The candidate list can constitute a requirement list for consumers and retailers. When asked by a consumer whether a certain product contains a substance listed on the SHVC list, the retailer has a legal obligation under REACH Regulations to comply.
How do I comply with REACH Regulations?
Manufacturers, Importers, Distributors, Retailers and Downstream users all have responsibilities under REACH. In addition to this, substances, preparations and articles are subject to different provisions under REACH. Meanwhile, non-EU companies and EU companies also have different obligations.
In brief, under REACH manufacturers and importers must register, with the European Chemicals Agency (ECHA), each substance manufactured or imported in quantities of more than 1 tonne per year and Downstream users’ will have a range of obligations under REACH legislation which primarily relate to ensuring the safe use of the chemical product, as well as providing information and documents to further downstream customers. This will mean that your products will need to be tested at an independent laboratory in order to ensure REACH compliance.
Why do I need to comply with REACH Regulations?It is a criminal offence to fail to comply with REACH regulations. Regardless, of your position within the supply chain you will have legal responsibilities under this legislation. Enforcement decisions are made on a case by case basis with compulsory measures ranging from withdrawal of products from the market and import rejections through to fines and even imprisonment.