The Court of Justice of the European Union (CJEU) recently ruled that a substance of very high concern (SVHC) applies to each article in a complex product rather than the entire product under REACH. The ruling can be considered as immediate.
The European REACH Regulation [1] (Registration, Evaluation, Authorisation and Restriction of Chemicals) is a comprehensive piece of legislation for the management of substances to ensure a high level of protection of human health and the environment.
Under Article 3(3), an article is defined as 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.
Under Article 7(2) ‘Notification of substances in articles’, a producer or importer of articles containing a substance of very high concern (SVHC) on the Candidate List is required to submit a notification to the European Chemicals Agency (ECHA) if the following conditions are met:
- The concentration of the SVHC is more than 0.1% in articles and
- The total quantity of the SVHC in articles is greater than 1 tonne per producer or importer per year
Under Article 33 ‘Duty to communicate information on substances in articles’, a supplier of an article containing an SVHC on the Candidate List in a concentration of more than 0.1% shall provide the recipient of the article with sufficient information, available to the supplier, to allow the safe use of the article, including, as a minimum, the name of the SVHC.
In April 2011, the ECHA published a guideline [2] for substances in articles to assist industry to comply, among others, with Article 7(2) and Article 33 of REACH. This guidance document revealed that the threshold limit of 0.1% of an SVHC in an ‘article’ applies to the ‘entire article’ (complex article or whole product) at the EU level. The guideline also informed that 7 EU/EEA Member States (MS) (Austria, Belgium, Denmark, Germany, France, Norway and Sweden) have dissenting views on applying the threshold limit of 0.1% of an SVHC to an entire article. These MS applied this threshold limit to ‘each article in an entire article’ (each component in an entire article) rather than to an ‘entire article’ as adopted by the European Commission and the ECHA’s guidance for substances in articles. The concept by these 7 EU/EEA MS was, in simple terms, ‘once an article, always an article’. This was further explained in a separate guidance document [3] dated July 2013; a guideline to assist suppliers of articles on how to carry out their legal duties regarding SVHCs on the Candidate List. Since then, the ECHA and European Commission on one side and the MS with dissenting views on the other have not been able to find a consensus on the interpretation of an article regarding REACH duties to inform about SVHCs for operators in the supply chain.
On 10 September 2015, a press release [4] by the Court of Justice of the European Union (CJEU) announced that the ‘Notification’ of an SVHC in an article under the REACH Regulation applies to ‘each article in an entire article’ (each component in an entire article) rather than to the ‘entire article’ when the concentration of an SVHC is more than 0.1%.
The CJEU’s ruling [5] was in line with the 7 EU/EEA MS and contradicted the views adopted by the European Commission and ECHA’s guidance for substances in articles. This ruling was not only restricted to manufacturers and importers in providing information to recipients and consumers of an article but to all economic operators along the supply chain when the economic operator supplies an article to a third party.
The new ruling did not indicate an effective date but can be considered as immediate. Highlights of the new ruling for Article 7(2) and Article 33 of REACH are summarised in Table 1.
TABLE 1
REACH Interpretation of Article for ‘Communication in Supply Chain’ and ‘Notification’ | |||
|---|---|---|---|
Item | Article Number | ECHA Guidance dated April 2011 | CJEU Ruling dated 10 September 2015 |
1 | 7(2) 'Notification of substances in articles' Notification by producer or importer required if an SVHC is:
| Entire article (Whole product) EU / EEA Member States with dissenting views:
| Each article in an entire article (each component article contained in a complex product) |
2 | Article 33 'Duty to communicate information on substances in articles' A supplier of an article containing an SVHC on the Candidate List in a concentration of > 0.1% shall provide the recipient of the article with sufficient information, available to the supplier, to allow the safe use of the article, including, as a minimum, the name of the SVHC | ||
Highlights of some illustrative examples on demonstrating how to apply the information duties with reference to the guideline ‘Guidance for Suppliers of Articles – The REACH Duties to inform about Candidate List Substances” [6] dated July 2013 are summarised in Table 2. These do not necessarily reflect the current understanding of the ECHA or European Commission.
Table 2
Example | Item | Description | Applying Trigger Limit |
|---|---|---|---|
Coated cable
| | The cable is for professional use and consists of a core of copper wire with a PVC coating. The copper wire is an article before production of the cable, while the PVC is a liquid mixture | The PVC coating contains benzyl butyl phthalate (BBP) but the coating was a mixture before production of the cable. The first article that contains BBP is the cable. The first article that contains BBP is the cable. Thus, the 0.1% limit should be applied to the whole cable. |
| The t-shirt has a print. The raw material for the print is delivered to the production site as liquid paint in different colours.
| The paint was a mixture and not an article before production of the T-shirt. The first article that contains bis(2-ethylhexyl) phthalate (DEHP) is the T-shirt. Thus, the 0.1% limit with respect to the DEHP content has to be applied to the T-shirt with the print. | |
A printed circuit board (PCB)
| The PCB consists of a plain layered board with printed wires, electronic articles and other components which are often fastened with solders or glue. Both the PCB and the added articles and mixtures consists of a series of different materials. E.g. rigid and soft plastics, metals, ceramics, glass etc. | The fact that the PCB is assembled from many small articles does not change the requirement that the trigger limit must be applied to any object within the PCB that is identified as an article. The large number of articles (such as various electronic articles, the fan, the board itself, etc.), and that many of them are soldered and/or glued to the PCB, may, however, make it a challenge to determine which of them that existed as articles already before production of the PCB. |
Operators along the supply chain must now re-evaluate the risk of their products containing > 0.1% SVHC on the component article level and resulting duties to communicate information in the supply chain or provide a notification. Also, ECHA’s information on SVHCs in articles [7] must be treated with care since the provided information from notifications are based on the interpretation of an article which was overruled.
Throughout our global network of laboratories, we are able to provide a range of services, including analytical testing and consultancy, for SVHCs and other restricted substances in consumer products for the European and international markets. Please do not hesitate to contact us for further information.
For enquiries, please contact:
Hing Wo Tsang
Global Toys and Juvenile Products
t: +852 2774 7420
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