How much do you know about the chemical composition of the products you place on the market in the European Union?
This is a relatively simple question, but can you really say that you know everything about the substances contained in the products you place on the market?
REACH expects manufacturers and importers of products in the EU to be aware of the content of the products placed on the market down to a concentration of 0.1 per cent. Manufacturers and importers are expected to tell clients and consumers if a product contains any Substances of Very High Concern (SVHC).
As part of its series of free webinars on Environmental, Health and Safety issues, in May 2009 Enhesa hosted two webinars to raise the awareness of businesses on the SVHC obligations and provide solutions on how to ensure compliance. To help us understand how business is dealing with the SVHC obligations, Enhesa surveyed businesses
prior to the webinars, with surprising results.
REACH requires that businesses know what is in their products
Under REACH, authorization is required for the use and placing on the market of substances with properties of very high concern when these substances are included in Annex XIV. Before a substance is listed in Annex XIV, it is listed in a Candidate List. Article 33 (1) of the REACH Regulation (EC/1907/2006) provides that suppliers of products (articles) containing a substance included in the Candidate List in a concentration above 0,1 % weight by weight (w/w) must provide the recipient of the article with sufficient information to allow the safe use of the article. This information must include, at a minimum, the name of the substance. There is no volume trigger for this obligation – the obligation will apply to any product, even if it is manufactured or imported in volumes of less than 1 tonne per year. Products or
components cannot be exempted from this obligation via the exemptions in Article 7(3) (exclusion of exposure) or via Article 7(6) (already registered for that use).
These measures became mandatory immediately upon the publication of the first batch of substances in the Candidate List of SVHC on the ECHA website on 28 October 2008. A second batch of substances is expected to be included in the Candidate List before the end of 2009. Consultation on this second batch ended on 15 October 2009. This batch includes, for example, Refractory Ceramic Fibres and 2,4- Dinitrotoluene. Moreover, information that is deemed necessary to ensure the safe use of an article also has to be provided to consumers upon request (Article 33 (2)). Consumers must be provided with information free of charge within 45 days of making the request.
Enhesa’s survey shows that many businesses are struggling to meet the challenge
Enhesa’s survey on SVHC took place in May 2009 and included respondents from various industry sectors, including manufacturers of electric and electronic equipment, the automotive industry and the aerospace and defence industries. Unlike other provisions in REACH, the SVHC requirements have an impact on big and small manufacturers,
because there are no exemptions for low volumes of substances.
According to the Enhesa survey:
– Only 34 per cent of companies surveyed know enough about what is in their product to be able to ensure compliance.
– Of the companies who know what is in their product, 45 percent had identified SVHC in at least some products.
– 12 percent of companies surveyed had already withdrawn products from the market because they contained SVHC.
– Of the companies that had identified products containing SVHC, 33 per cent of them had not yet communicated the
presence of SVHC down the supply chain.
Most companies are aware only of the main chemicals that are included in the products they place on the market. If a company does not identify any SVHC in its products, it is not required under REACH to provide a declaration stating the absence of SVHC. However, some companies have adopted this strategy to assure consumers that their products do not pose a chemical risk. But of the companies Enhesa surveyed that knew that their products do not contain SVHC, two thirds had not made such a declaration.
On the bright side, the majority of the companies Enhesa surveyed said they were aware of the content of SVHC in their products and maintain a list of chemicals banned from products. To communicate the presence of SVHC to the supply chain, most survey participants use either a self-made declaration or adapt a format prepared by the industry association of which they are members.
Companies must ensure they are in compliance
Enhesa advises that companies establish processes to identify the chemicals that are present in products and whether any of these are listed as candidate substances of very high concern. A compliance system should address contractual issues with suppliers of raw materials and subcomponents, and will need to be able to adjust to an ever-changing list of candidate SVHCs.
The SVHC requirements can have a very significant impact on a company’s operations. If a company’s product contains a SVHC, the company should consider replacing the SVHC with safer substances. The company may also need to consider whether it is worth continuing the product line, which may put the corporate reputation at risk.
The Candidate List currently contains only 15 substances, but it will potentially contain hundreds. Companies need to be prepared. Enhesa is following development in the Candidate List and Annex XIV and can help companies identify their obligations under REACH. If you, like so many other companies, need help in making sense of the latest REACH developments and what they mean for your company, feel free to contact Enhesa to obtain additional support and advice.
Vito A. Buonsante