13 July 2018
Newly Expanded Candidate List of Problematic Substances Triggers Reporting and Information Obligations for Some Suppliers
On 27 June 2018, the European Chemicals Agency (ECHA) announced that it has updated the EU’s Candidate List by adding 10 new Substances of Very High Concern (SVHCs) to that List. The Candidate List now contains 191 SVHCs. While the update doesn’t (yet) ban any of the newly listed substances, economic operators including those hailing from Hong Kong should be aware of the substances that have been added. This is because of the various obligations – especially on suppliers of articles (finished or semi-finished products) – that are immediately triggered. The newly added substances and their named uses, are as follows:
- Octamethylcyclotetrasiloxane (D4) and Dodecamethylcyclohexasiloxane (D6): Used in washing and cleaning products, polishes and waxes, and cosmetics and personal care products.
- Decamethylcyclopentasiloxane (D5): Used in all of the above, as well as in textile treatment products and dyes.
- Lead: Used in metals, welding and soldering products, metal surface treatment products, and polymers.
- Disodium octaborate: Used in anti-freeze products, heat transfer fluids, lubricants and greases, and washing and cleaning products.
- Benzo[ghi]perylene: Normally not produced intentionally but rather occurs as a constituent or impurity in other substances.
- Terphenyl hydrogenated: Used as a plastic additive, solvent, in coatings/inks, in adhesives and sealants, and heat transfer fluids.
- Ethylenediamine (EDA): Used in adhesives and sealants, coating products, fillers, putties, plasters, modelling clay, pH regulators and water treatment products.
- Benzene-1,2,4-tricarboxylic acid 1,2 anhydride (trimellitic anhydride) (TMA): Used in the manufacture of esters and polymers.
- Dicyclohexyl phthalate (DCHP): Used in plastisol, PVC, rubber and plastic articles. A further use is also as a phlegmatiser and dispersing agent for formulations of organic peroxides.
It was also reported on 27 June 2018 that an EU-based chemicals association has warned of the potential for disruptions in trade by adding the three substances D4, D5 and D6. They are said to have uses as chemical intermediates for the production of silicone rubbers, gels and resins. These, in turn, have applications in the production of window sealants, solar panels, vehicle airbags, healthcare products and many other products. Such uses, it is argued, vastly outweigh the uses named by ECHA. According to the association, there are no alternatives to producing silicone.
Hong Kong sellers of especially articles, e.g., commonly used products such as electronics, toys and textile goods, may already be aware of the Candidate List, which is a list of substances that are considered dangerous for human health or the environment. Substances on the Candidate List are “candidates” for eventual inclusion in the Authorisation List (Annex XIV of the REACH Regulation). Once they are on the Authorisation List, companies will need to apply for authorisation to continue using the substance after a so-called “sunset date”. SVHCs may also, in the future, be restricted by Annex XVII of the REACH Regulation, for use in consumer products placed on the EU market.
The main obligations that Hong Kong suppliers (of articles) should be aware of are the following. Inclusion on the Candidate List triggers notification and provision-of-information obligations under Articles 7.2 and 33 of the REACH Regulation respectively. Under Article 7.2 of the REACH Regulation, the use of any chemical that is found on the Candidate List must be notified to ECHA by the EU producer or importer, whenever the SVHC concentration exceeds 0.1% weight by weight (w/w) of the article in question, in quantities totaling over one tonne per producer or importer per year. Only limited exemptions from this notification obligation apply, as laid out in Article 7.
Under Article 33 of the REACH Regulation, whenever an SVHC appears on the Candidate List, suppliers of articles containing it above a concentration of 0.1% (w/w) must also provide the downstream 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. Consumers also have the right to this information, but only on request. There are no tonnage thresholds or any exemptions whatsoever from this provision-of-information obligation.
The interpretation of this 0.1% (w/w) threshold has been controversial. In 2015, the Court of Justice of the EU has clarified the scope of the notification and communication obligations by deciding that the 0.1% (w/w) threshold shall apply to each simple article that comprises the entire complex article. ECHA’s 2017 Guidance on requirements for substances in articles provides detailed examples that are consistent with the Court’s conclusions.