A guide to the REACH regulations

Author : Dr Helen Steele, Intertek MSG

08 February 2013

REACH is the European Regulation (EC) No 1907/2006 Registration, Evaluation, Authorisation and Restriction of Chemical substances. The regulation  was introduced to ensure safe production, use and management of substances in Europe and covers the life cycle of substances including their use in articles.

The REACH definition of an article is an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition.

Electrical and electronic products are classed as articles. The products themselves, their power cables, packaging and instruction manuals are all considered to be separate articles.

One of the aims of REACH is to identify those substances that are the most hazardous to human health and the environment and control their use in Europe through the processes of Authorisation and Restriction. Authorisation is the process whereby Substances of Very High Concern (SVHC) are identified and eventually replaced by less dangerous substances or technologies where suitable economically and technically viable alternatives are available. The presence of >0.1% of an SVHC in an article triggers obligations in the supply chain. The Restrictions Annex XVII of REACH lists substances either by name or in groups dependent on their classification and describes their restriction.  A substance on its own, in a preparation or in an article, for which Annex XVII contains a restriction shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction.

Many European companies pass the responsibility for their REACH compliance on to their suppliers. The REACH compliance status of suppliers will impact a company’s own REACH obligations, however, there are some obligations which are linked to the supply of articles and the responsibility is with the article supplier, not those companies further up the supply chain.

It is a criminal offence to not comply with the REACH Regulation and penalties include fines and prison sentences. REACH compliance is enforced by the UK Competent Authority, the Health and Safety Executive (HSE).

Here is a guide to understanding your obligations under the REACH Regulation.

How does the legislation affect electrical product manufacturers?

Electrical product manufacturers may use substances in the production of their articles, and according to REACH this would make them Downstream Users (DU). As DU, they need to check that their uses of the substances are covered in the registration dossiers of their suppliers otherwise they may have to report their use to the European Chemicals Agency (ECHA).

Electrical product manufacturers must ensure that their products comply with REACH Annex XVII Restrictions and that they fulfill their obligations if there are any SVHC present in their articles at >0.1%.

What are substances of very high concern (SVHC) and what sort of products are they found in?

SVHC are substances classified as follows:

? Categories 1 and 2 for carcinogenicity, mutagenicity or toxicity for reproduction (CMR)
? Persistent, bioaccumulative and toxic (PBT)
? Very persistent, very bioaccumulative (vPvB)
? Substances for which there is scientific evidence for probable serious effects to human health or the environment, such as endocrine disruptors.

There are more than a thousand substances in Europe known to fulfill the criteria to be identified as SVHC however the identification as SVHC is not automatic and all substances must go through an identification process. Currently, 84 substances have been identified as SVHC and they are listed on the Candidate List.

Fourteen of those SVHC have been added to the Authorisation Annex XIV and given “sunset dates”.

Substance Sunset date
4,4’-Diaminodiphenylmethane (MDA) 21/08/2014
5-tert-butyl-2,4,6-trinitro-m-xylene (Musk xylene) 21/08/2014
Benzyl butyl phthalate (BBP) 21/02/2015
Diisobutyl phthalate (DIBP) 21/02/2015
Dibutyl phthalate (DBP) 21/02/2015
Bis(2-ethylhexyl) phthalate (DEHP) 21/02/2015
Lead sulfochromate yellow (C.I. Pigment Yellow 34) 21/05/2015
Lead chromate 21/05/2015
Diarsenic pentaoxide 21/05/2015
Diarsenic trioxide 21/05/2015
Lead chromate molybdate sulphate red (C.I. Pigment Red 104) 21/05/2015
Tris(2-chloroethyl)phosphate (TCEP)  21/08/2015
2,4 – Dinitrotoluene (2,4-DNT) 21/08/2015
Hexabromocyclododecane (HBCDD), alpha-hexabromocyclododecane, beta-hexabromocyclododecane, gamma-hexabromocyclododecane 21/08/2015

After the sunset date these chemicals cannot be manufactured, imported or used within Europe without Authorisation. The purpose of an Authorisation is to allow a company to continue using an SVHC while actively researching viable alternatives.

Every 6 months, ECHA publish a document that provides information on the types of consumer articles known to contain SVHC. Many SVHC are used in plastics, pigments, lacquers, adhesives, flame retardants, corrosion inhibitors and high temperature insulation. Specific examples include:

Phthalates - such as DBP, DEHP and BBP are mainly used as plasticisers in polymers such as PVC. These have been notified as present in electronic and plastic articles as well as machinery. They can be present in wire insulation on electrical articles and in packaging materials.

HBCDD - with its flame retardant properties, can be found in the plastic housing of electrical/electronic articles.

TCEP - is used primarily as a plasticiser with flame-retarding properties for polyurethane, polyesters, polyvinyl chloride and other polymers.

SVHC and Articles: what are my obligations?

When importing, producing or supplying an article the main obligations relate to knowing the chemical composition of the article. It must comply with REACH Restrictions Annex XVII and the presence and concentration of any SVHC must be known. Once a substance is added to the Candidate list, it is identified as SVHC and the following obligations apply:

Producers or importers of articles shall notify the ECHA if there is an SVHC present in an article at >0.1% by weight and the substance is present in quantities totalling over 1 tonne per producer or importer per year. Notification must occur within 6 months of that substance being added to the Candidate List. If the substance is already registered for that use in the supply chain, or the article producer can exclude human exposure under normal conditions of use, no notification is required. So, knowledge of the REACH compliance status in the supply chain is important.

Electrical product suppliers need to know if there are any SVHC present at >0.1% in the articles they supply. If there is, the supplier must automatically provide guidance on safe use to the article recipient (not consumers). If supplying the same articles to consumers, the information must be provided free of charge and within 45 days of receiving a request. It is recommended the information is kept readily available.

How do I know what SVHC my Articles contain?

If you are sourcing articles from European suppliers, they should provide you with information about any SVHC present and it’s safe use. If you are importing the components from non-European suppliers it is important to know their REACH compliance status. Non European article producers can use an Only Representative to fulfill all their REACH obligations which would remove importer obligations from the company importing the article into EU. If the non European supplier does not have an Only Representative, then it is important to have a strategy of your own to ensure that you know if any SVHC are present in your articles and at what concentration.

Testing your entire product range for all SVHC is unnecessary as it’s unlikely that all or even several of the SVHC will appear in one article. If you use flame retardants, adhesives, sealants or even a certain type of pigment to colour your casings, these are going to be obvious articles that you can prioritise for assessment. A combined approach using information from suppliers, with a risk assessment and targeted screening analysis of articles with high potential to contain SVHC should provide a clear picture of SVHC present in your products. If SVHC are present, then detailed testing can be done to quantify them.

How do I communicate details of risk and safe use of articles?

There is no fixed format for communication of safe use of articles containing >0.1% SVHC. It can be achieved through product labelling, instructions for use or by providing a link to a webpage.

Evaluation of supplier information?

When working with European suppliers, they should provide the information, as long as they are aware of their REACH obligations. If in doubt, one option is to speak to a chemical laboratory to identify potential liabilities in products or components.

Compliance tips

Assess your suppliers for their level of REACH compliance
Document your REACH compliance and SVHC assessment procedures
Create purchasing specifications that include Restrictions and SVHC data requirements
Be aware of updates to the Candidate list
Be prepared to respond to information requests from consumers

Contact Details and Archive...

Print this page | E-mail this page