EU considers expanding scope for phthalate restriction

The European Chemicals Agency (ECHA) has submitted a proposal to restrict four phthalates (DIBP, DBP, BBP, DEHP) aiming to expand the scope for phthalate restriction and also grant exemptions for phthalates exposed to common people.

The current REACH Annex XVII only sets forth restriction for DEHP, DBP, BBP, DINP, DIDP and DNOP in toys and child care articles, while other products are not regulated; although the four substances (DEHP, DIBP, DBP and BBP) are now authorised, Echa and Denmark believe a risk remains from exposure to all articles, including imported products not covered by authorisation. Consequently, the risk of phthalate cannot be adequately controlled.

The proposed restriction:

Substance

Proposed restriction

Bis(2-ethylhexyl) phthalate (DEHP) EC number: 204-211-0 CAS number: 117-81-7 Benzyl butyl phthalate (BBP) EC number: 201-622-7 CAS number: 85-68-7 Dibutyl phthalate (DBP) EC number: 201-557-4 CAS number: 84-74-2 Diisobutyl phthalate (DIBP) EC number: 201-553-2 CAS number: 84-69-5

1. Articles containing DEHP, DBP, DIBP, and BBP in a concentration, individually or in combination, greater than or equal to 0.1% by weight of the plasticised material shall not be placed on the market. 2. Paragraph 1 shall apply three years from the entry into force of the restriction. Paragraphs 1 and 2 shall not apply to: a. articles only for outdoor use where the phthalate-containing material is not in prolonged contact with human skin or any contact with human mucous membranes "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 discontinuously. “Only for outdoor use” should in this context be understood as articles which are not used or stored in the interior of dwellings where humans are present under normal and reasonably foreseeable conditions. b. articles only for use in industrial or agricultural workplaces. This derogation does not apply to articles where the phthalate-containing material is in prolonged contact with human skin by workers. c. measuring devices for laboratory use d. articles placed on the market in the European Union prior to the date in paragraph 2. Paragraph 1 and 2 shall not apply to articles covered under existing legislation: i. Food contact materials covered by Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011 on plastic materials. ii. Immediate packaging of medicinal products covered by Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC, or to medical devices covered by Directive 90/385/EEC, Directive 93/42/EEC or Directive 98/79/EC. iii. Toys and childcare articles containing DEHP, DBP and BBP covered by existing restriction entry 51 in Annex XVII of REACH ‘Childcare

These articles include mainly:
• flooring,
• coated fabrics and paper,
• recreational gear and equipment,
• mattresses,
• footwear,
• office supplies and equipment,
• wires and cables, and
• other articles moulded from or coated with plastic.

There is a three-year transitional period granted in the proposal to ensure businesses can better adapt to the new restrictions.

The proposal is expected to be under discussion in September REACH Committee meeting. C&K Testing advises businesses to pay due attention.