26 Jan 2018
EU Updates REACH List of Hazardous Substances, Triggering Obligations on Economic Operators
On 15 January 2018, the European Chemicals Agency (ECHA) announced that it has updated the EU’s Candidate List of Substances of Very High Concern (SVHCs). The List now contains 181 SVHCs. While the update doesn’t (yet) ban any of the substances, economic operators including those hailing from Hong Kong should be aware of the substances newly added to the Candidate List. This is because of the various obligations – especially on articles producers – that are immediately triggered once a substance is added onto the List, as explained further below.
The 15 January announcement states that the list was updated after ECHA added seven new SVHCs to the Candidate List and updated the entry for bisphenol A (BPA). This followed the SVHC identification process with the involvement of Member States’ representatives. Some of the substances can be used in consumer goods, including electronics and cosmetics.
The newly added substances (or the newly updated substance in the case of BPA), and their likely uses, are as follows:
- 4,4’-isopropylidenediphenol (bisphenol A; BPA): Used in the manufacture of polycarbonate, as a hardener for epoxy resins, as an anti-oxidant for processing PVC and in thermal paper production. The update is due to its now being classed as an endocrine disruptor.
- Chrysene and Benz[a]anthracene: Both these substances are normally not produced intentionally but rather occur as a constituent or impurity in other substances.
- Cadmium nitrate: Used for the manufacture of glass, porcelain and ceramic products and in laboratory chemicals.
- Cadmium hydroxide: Used for the manufacture of electrical, electronic and optical equipment and in laboratory chemicals.
- Cadmium carbonate: Used as a pH regulator and in water treatment products, laboratory chemicals, cosmetics and personal care products.
- 1,6,7,8,9,14,15,16,17,17,18,18- Dodecachloropentacyclo[22.214.171.124,9.02,13.05,10]octadeca-7,15-diene (“Dechlorane Plus”TM) [covering any of its individual anti- and syn-isomers or any combination thereof]: Used as a non-plasticising flame retardant, used in adhesives and sealants and in binding agents.
- Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) [with ≥0.1% w/w 4-heptylphenol, branched and linear: Used as a lubricant additive in lubricants and greases.
Hong Kong sellers of especially articles, e.g., commonly used products such as toys, electronics and textile goods, may already be aware of the Candidate List, which is a list of substances that may have serious effects on human health or the environment. Substances on the Candidate List are also known as SVHCs, and are candidates for eventual inclusion in the Authorisation List (Annex XIV of the REACH Regulation). Once they are on the Authorisation List, industry will need to apply for permission to continue using the substance after a so-called ‘sunset date’. SVHCs may also, in the future, be restricted by Annex XII of the REACH Regulation, for use in consumer products.
The main obligations that Hong Kong suppliers (of articles) should be aware of, which are immediately triggered once a substance is placed on the Candidate List, are the provision-of-information obligations down the supply chain and the notification obligation.
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 totalling over one tonne per producer or importer per year. Only limited exemptions from this notification obligation apply.
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.