On 29 June 2011, the European Chemicals Agency (ECHA) issued a helpful shortened version of the guidance documents on the requirements for substances in articles, which are laid out in the REACH Regulation. The shortened guidance will be of special interest to companies that sell their goods to Europe's customers, as it provides a number of clarifications regarding the obligations companies placing articles on the European market are required to meet.
The REACH Regulation, adopted in 2006, has quickly become one of the most voluminous instruments of EU legislation to date. The need for guidance in order that companies may fulfil their obligations under REACH remains significant. The recent updated and shortened guidance document aims at addressing this need for some important provisions of REACH in a practical manner.
REACH applies to chemical substances, mixtures of substances and articles that contain chemicals. Companies will recall that any object the function of which is determined more by its shape, surface or design, rather than by its chemical composition, is considered to be an article for the purposes of REACH. What is certain is that everyday consumer goods, ranging from toys, clothing, and electronic equipment, to passenger cars, are considered articles.
Most of the requirements that REACH lays down are intended for producers and importers of goods active within the EU. However, ECHA stresses the importance of the obligation to communicate information on substances in articles: an obligation which falls not only on producers and importers of articles within the EU, but - effectively - also on the wider category of suppliers, regardless of where in the world they are established.
Regarding this obligation to communicate, the ECHA provides some clarification. In essence, the requirement is the following: whenever more than 0.1% of an article consists of products which can seriously affect human health or the environment, the supplier is obliged to provide recipients down the supply chain with relevant safety information. The same obligation applies where a consumer makes a request for this information.
This obligation raises a series of questions. First, when does a product have the potential of seriously affecting human health or the environment? ECHA has drawn up a "Candidate List of Substances of Very High Concern for Authorisation"; all substances on this list (which is growing) are deemed dangerous and are thus called Substances of Very High Concern (SVHCs). If more than 0.1% of the article consists of a substance mentioned in the Candidate List, then the communication obligation applies.
Second, how is the 0.1% threshold calculated? Here, useful clarifications are provided in the guidance document. First and foremost, it is interesting to note that the obligation to communicate applies, potentially, for all articles, regardless of their quantity (e.g., even if below one tonne per year). Furthermore, it is noteworthy that the packaging of an article is treated as a separate article from the contents of the package. Therefore, the obligation to communicate information on SVHCs applies to the packaging as well.
Third, to whom does the information need to be provided and when? All suppliers have to automatically inform recipients (downstream actors in the supply chain) of the SVHCs in their products. All industrial or professional users and distributors are considered recipients; consumers are not. On the other hand, suppliers need to inform consumers at the latter's request. Suppliers need to answer consumer enquiries within 45 days, free of charge.
The obligation to communicate to consumers is reportedly being tested by NGOs and environmentalists, with requests being sent out to major retailers all over the EU to see whether they comply with this obligation.
Fourth, what is meant by "relevant safety information"? In other words, what kind of information does the supplier need to provide? Here, the guidance considers relevant safety information as "the information necessary to allow safe use of the article." Suggestions are given: "the supplier has to consider how the article is used, which exposures and risks could arise and which information, in particular, or risk management, is required for the user of the article to ensure safe handling." The service life of the product should be considered, as well as instructions for its disposal, specific storage or transport conditions. In any case, as a minimum, the name of the substance in question needs to be communicated.
Fifth, how does this information need to be provided? The REACH regulation does not specify a format. The document mentions that companies must choose a format that will ensure that the information is readily available to the recipient of the article or the consumer.
Since communication has become a legal requirement for companies active within the EU, the need for these companies to have access to reliable information as to the composition of articles imported has increased significantly. Therefore, the ECHA stresses the importance of supply chain communication.
Retailers of, for example, consumer goods rely on their (upstream) suppliers for correct information. Companies responsible for the production of many of the consumer goods brought into circulation on the EU market, thus face an important responsibility. ECHA in this guidance explicitly proposes that companies at the bottom of the supply chain contact producers, formulators and manufacturers directly and pro-actively. ECHA proposes that suppliers introduce certificates which would guarantee to their buyers that certain substances are not used in the manufacture of products or remain below certain concentrations. A second proposal is to supply contracts excluding or limiting the presence of certain substances. Both proposals are novel to this guidance.
Producers and importers of articles may also have to comply with the obligation of the notification of substances in articles. This involves the submission of specific information on a substance and its uses in articles, as well as the use of the article, to ECHA. Notification of a substance in articles is required by an EU articles producer or importer when the substance is an SVHC in the Candidate List; it is present in the articles at a concentration of above 0.1%; and the total amount of the substance present in all articles produced and/or imported, which contain more than 0.1% of the substance, exceeds 1 tonne per year for the producer/importer. However, exemptions apply.
For more details, companies should peruse the guidance via the links below.
The guidance document on substances in articles issued on 29 June 2011 can be accessed at:
More extensive guidance on the same topic can be accessed at: