Relevant for: Hardlines, Softlines, Toys & children's products
On 22 March 2017, the European Chemical Agency (ECHA) launched the 2nd public consultation1 on the proposal to restrict the four phthalates2 (Bis(2-ethylhexyl) phthalate (DEHP), Dibutyl phthalate (DBP), Diisobutyl phthalate (DIBP) and Benzyl butyl phthalate (BBP)), under REACH Annex XVII.
After the 1st public consultation, the original proposal was modified by the Socio-Economic Assessment Committee (SEAC) on the restriction conditions of four phthalates and adding the proposal to include DIBP into REACH Annex XVII entry 51. All interested parties can comment on the SEAC’s draft opinion3 using the ECHA website until the end of the consultation period on 22 May 2017.
After the 2ndpublic consultation, the ECHA will submit the final opinions to the European Commission (EC) to see if it is needed to amend Annex XVII.
Table A and B below shows the details of the proposed restriction on the four phthalates and the proposed amendment on Annex XVII entry 51, which were modified by the SEAC.
Table A. Proposed restriction on DEHP, DBP, DIBP and BBP
|Proposed scope of restriction|
- 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 interior space where people are present under normal and reasonably foreseeable conditions and potentially exposed via inhalation.
Examples of products within scope:
- coated fabrics and paper
- recreational gear and equipment
- office supplies and equipment,
|Proposed limit||≤ 0.1% by weight (individually or in combination) of the plasticised material|
- Articles only for use in industrial or agricultural workplaces
- Measuring devices for laboratory use
- Articles covered under existing legislation:
- Food contact materials covered by Regulation (EC) No 1935/2004 and Regulation (EU) No 10/2011 on plastic materials
- Immediate packaging of medicinal products covered by Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC,
- Medical devices covered by Directive 90/385/EEC, Directive 93/42/EEC or Directive 98/79/EC
- Electrical and electronic equipment covered under Directive 2011/65/EU
- Toys and childcare articles covered by existing restriction entry 51 in Annex XVII of REACH
- Articles which it can be demonstrated that they are placed on the market for the first time in the European Union (EU) prior to the date of application (3 years from the date of entry into force)
|Proposed date of application||3 years from entry into force|
Table B. Proposed amendment of REACH Annex XVII entry 51 – include DIBP into the scope
|Existing restriction of entry 51||Proposed restriction of entry 51|
|DEHP, DBP, BBP in the plasticised materials of toys and childcare articles: ≤ 0.1% by weight||DEHP, DBP, BBP, DIBP in the plasticised materials of toys and childcare articles: ≤ 0.1% by weight|