7 April 2017
Restriction of Phthalates in Wide Variety of Consumer Goods Foreseen
On 21 March 2017, the European Chemicals Agency (ECHA) reported that its two main committees have agreed on a restriction proposal concerning four phthalates (DEHP, DBP, DIBP and BBP) contained in articles. In so doing, they have backed the proposal by ECHA and Denmark over the future restrictions.
Hong Kong’s manufacturing community should be aware that the recommendation is to ban phthalates in articles that cause exposure through the skin or by inhalation. The articles covered would include flooring, coated fabrics and paper, recreational gear and equipment, mattresses, footwear, office supplies and equipment, and other articles moulded or coated with plastic.
The expert committees concluded that the proposed restriction is the most appropriate EU-wide measure to address the identified risks in terms of the proportionality of its socio-economic benefits vs. its costs.
The phthalates targeted under the ECHA proposal are Bis (2-ethylhexyl) phthalate (DEHP), Benzyl butyl phthalate (BBP), Dibutyl phthalate (DBP), and Diisobutyl phthalate (DIBP). These substances are plasticisers that are commonly used in consumer goods, and, in particular, in polyvinyl chloride (PVC) based products.
As Hong Kong traders of products incorporating plastics are likely aware, phthalates were already classified as substances of very high concern (SVHCs) under the REACH chemicals regime due to their toxicity to reproduction and were included in the REACH Candidate List in 2008 and 2010. A previous REACH committee vote on the identification of these phthalates as endocrine-disrupting chemicals (EDCs) in 2014 resulted in DEHP being merely classified as an EDC for the environment but did not achieve consensus with respect to the classification of all four phthalates, nor to new EU-wide restrictions.
The Danish Environmental Agency led the effort to classify these substances as EDCs. In parallel, this agency also spearheaded an effort to push ECHA to issue a proposal banning the use of these four phthalates in certain consumer goods.
In consequence, on 16 March 2017, the Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC) published an opinion in favour of an ECHA dossier proposing new restrictions on the use of these four phthalates in the EU.
Specifically, the proposal would impose a ban on several types of consumer articles (such as the ones mentioned above, e.g., footwear, mattresses, etc.) destined for consumers containing a concentration of over 0.1% of any of the four phthalates concerned, whether alone or in combination.
Wires and cables, which had been included in ECHA’s first proposal (see: Proposal Submitted to Restrict Four Phthalates in a Wide Array of Consumer Goods of the Regulatory Alert-EU), have since been excluded from the scope of the proposal as the use of phthalates in these products is already being phased out under the EU’s RoHS Directive targeting electrical and electronic equipment.
Traders may be somewhat relieved to note that the proposal explicitly excludes:
- Outdoor goods not used and stored in dwellings where people are present under normally foreseeable conditions and whose phthalate-containing material is not in prolonged contact with human skin (i.e. daily skin contact of over 10 minutes continuously or 30 minutes overall); and
- Tools used for conducting laboratory measurements.
Also excluded are goods already restricted by existing EU legislation (i.e. food packaging or food contact materials, immediate medicinal product packaging, medical devices, and toys and childcare items).
Moreover, Hong Kong companies evaluating the potential impact of this restriction on their trade should note that the ban will not apply to articles placed on the EU market before the restriction enters into effect, nor during a three year transitional period following that date.
Approval by the ECHA committees is one of the preliminary steps in the legislative process. Now that the RAC and SEAC have issued their agreement to the restriction proposal, the proposal must pass through the European Commission’s committee procedure.
Meanwhile, certain environmental groups have criticised the restricted scope of ECHA’s proposal. In particular, a coalition of 31 such organisations has lobbied for the restrictions to be explicitly extended to cleaning and personal care products such as skin creams and hair gels. It appears, however, that the RAC and SEAC have chosen not to expand the ban’s reach in this way.
Please click on the following in order to examine the RAC and SEAC Opinion dated 16 March 2017.