13 May 2016
Proposal Submitted to Restrict Four Phthalates in a Wide Array of Consumer Goods
On 1 April 2016, the European Chemicals Agency (ECHA) submitted a proposal to restrict the use of four already-classified phthalates in consumer products, including those imported into the EU. The four substances proposed for restriction are: Bis (2-ethylhexyl) phthalate (DEHP), Benzyl butyl phthalate (BBP), Dibutyl phthalate (DBP) and Diisobutyl phthalate (DIBP).
Denmark had previously argued for extensive restrictions on phthalates in consumer products to protect human health. After an analysis conducted to identify the most appropriate measure to address these risks, ECHA has found that the identified risks to the general population are not sufficiently controlled, and need to be addressed.
These substances are used as plasticisers in various consumer products, mainly in polyvinyl chloride (PVC) goods. They are already on the so-called Authorisation List in Annex XIV of the REACH Regulation, and thus cannot be used in the EU without a specific authorisation. Should the restriction proposal be adopted into law, it will lead to a severe restriction of the substances in products circulating within the EU.
The restriction will impose a ban on the placing on the market of the following articles containing the four phthalates in a concentration, individually or in combination, in excess of 0.1% of the plasticised material:
- Any (indoor or outdoor) articles whose phthalate-containing material may be mouthed, or is in prolonged contact with human skin or any contact with mucous membranes, and
- Any phthalate-containing articles that are used (including stored) in an indoor environment where people are present under normal and reasonably foreseen conditions, and potentially exposed via inhalation. This does not apply to articles that are used only in industrial or agricultural workplaces.
“Prolonged contact with human skin” should in this context be understood as covering a daily overall contact with skin of more than 10 minutes continuously or 30 minutes intermittently.
The abovementioned paragraphs do not apply to:
- Articles placed on the EU market prior to the date of entry into effect, as well as during a three-year transitional period (Hong Kong traders should note that entry into effect is expected to take place in 2020);
- Articles covered (restricted) under already-existing EU legislation:
o on food contact materials;
o immediate packaging of medicinal products;
o medical devices;
o toys and childcare articles containing DEHP, DBP and BBP; and
- Measuring devices for laboratory use.
Hong Kong companies concerned by the impact on their trade of this future measure should know that the main products in scope would be: flooring; coated fabrics and paper; mattresses; footwear; office supplies and equipment; wires; cables; and other articles moulded from coated plastics.
The general population is believed to be exposed to phthalates in various ways and from different sources. Oral exposure occurs from ingestion of food and dust, and from the mouthing of articles. However, the main sources of exposure are considered to be food, indoor environment and direct contact.
The official restriction report prepared by ECHA indicates that the proposed limitation is capable of significantly reducing the risks to human health of combined exposure within a reasonable period of time, starting from 2020. The relevant competent authorities in the EU are also encouraged to take the necessary measures to reduce the risks relating to the four phthalates from food consumption.
According to ECHA, the restriction would be effective for various reasons: It would be targeted to exposures that cause the risks, it would reduce the identified risks within a reasonable period, and the benefits of risk reduction would exceed the costs.
Considering the accessibility of information regarding which articles may contain the four phthalates, and the experience that stakeholders hold, the level of administrative burden to implement the restrictions is anticipated to be low.