3 Jan 2019
New Regulation Will Restrict Phthalates in Consumer Goods EU-wide
Annex XVII of the REACH Regulation, into which the core provisions of Commission Regulation 2018/2005 will be inserted, prohibits or restricts the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles. According to the text of Commission Regulation 2018/2005, the four phthalates will be banned from articles used by consumers, or available in indoor areas, in a concentration equal to or above 0.1% by weight individually or in any combination in any plasticised material.
The articles to be covered by the new restriction will, to a great extent, be familiar to Hong Kong sellers, and include recreational gear and equipment, mattresses, footwear, office supplies and equipment, and other articles moulded or coated with plastic. The restriction takes into account the cumulative effects and combined exposure to the four phthalates from different products.
The four phthalates are considered to be substances of high concern due to their toxic effects on reproductive health. Consumers risk being exposed to one of these phthalates or to a combination of them through different sources, such as ingesting food and dust, placing articles in the mouth, breathing in air and dust indoors, or by dust coming into contact with mucous membranes and skin.
Hong Kong sellers of especially toys will be aware that Annex XVII of the REACH Regulation already bans the placing on the market of toys and childcare articles containing DEHP, DBP and BBP under certain conditions which fall within the scope of the restriction.
As Hong Kong traders of products incorporating plastics are likely aware, the phthalates were already classified as substances of very high concern (SVHCs) under the REACH chemicals regime due to their toxicity to reproduction. The Danish Environmental Agency first submitted a proposal to the European Chemicals Agency (ECHA) to restrict the four phthalates in 2011. However, at that time ECHA was of the view that the use of the chemicals did not pose a risk and therefore rejected the proposal in 2012. Thereafter, on 1 April 2016, ECHA, in cooperation with Denmark, submitted an Annex XV dossier (i.e., a restriction proposal) for the four phthalates. The dossier built on the previous restriction proposal submitted by Denmark in 2011.
Thus, the new provisions, to be henceforth set out as part of Entry 51 of Annex XVII of REACH, stipulate as follows:
- DIBP shall not be placed on the market after 7 July 2020 in toys or childcare articles, individually or in any combination with the other three phthalates (DEHP, BBP, DBP), in a concentration equal to or greater than 0.1% by weight of the plasticised material.
- DEHP, BBP, DBP and DIBP shall not be placed on the market after 7 July 2020 in articles, individually or in any combination of the phthalates, in a concentration equal to or greater than 0.1% by weight of the plasticised material in the article. The aforementioned restriction shall not apply to the following:
- articles exclusively for industrial or agricultural use, or for use exclusively in the open air, provided that no plasticised material comes into contact with human mucous membranes or into prolonged contact with human skin;
- aircraft, placed on the market before 7 January 2024, or articles, whenever placed on the market, for use exclusively in the maintenance or repair of those aircraft, where those articles are essential for the safety and airworthiness of the aircraft;
- motor vehicles within the scope of Directive 2007/46/EC, placed on the market before 7 January 2024, or articles, whenever placed on the market, for use exclusively in the maintenance or repair of those vehicles, where the vehicles cannot function as intended without those articles;
- articles placed on the market before 7 July 2020;
- measuring devices for laboratory use, or parts thereof;
- and food contact materials and articles; medical devices; electrical and electronic equipment; the immediate packaging of medicines; and toys and childcare articles, where any of these are already restricted by means of existing legislation.
- The new Regulation also defines ‘plasticised material’ as any of the following homogeneous materials:
- polyvinyl chloride (PVC), polyvinylidene chloride (PVDC), polyvinyl acetate (PVA), polyurethanes,
- any other polymer (including, among others, polymer foams and rubber material) except silicone rubber and natural latex coatings,
- surface coatings, non-slip coatings, finishes, decals, printed designs,
- adhesives, sealants, paints and inks.
- As for ‘prolonged contact with human skin’, this means continuous contact of more than 10 minutes duration or intermittent contact over a period of 30 minutes, per day.
Commission Regulation 2018/2005 enters into force on 7 January 2019, and will begin applying on the respective dates mentioned above, i.e., as from 7 July 2020, with a longer grace period of 60 months given to motor vehicles, aircrafts and their parts.