Proposed Restriction on Phthalates in indoor articles and articles in contact with skin or mucous membranes


Proposed Restriction on Phthalates in indoor articles and articles in contact with skin or mucous membranes

In January 2012, Denmark proposed a restriction of four phthalates (DEHP, BBP, DBP, DIBP) in indoor articles and articles that come in contact with skin or mucous membranes under REACH Annex XVII (EC 1907/2006). Suggested limits are 0.1% (1000 mg/kg) of one or more of these four phthalates. Comments on the proposed restriction can be given on the European Chemicals Agency (ECHA) website (see link below). The deadline for comments is 16 March 2012.

Background
Phthalates are mainly used as softeners in plastic materials and several regulations are already in place for phthalates:
  • DEHP, DBP and BBP are restricted under EC 1907/2006 Annex XVII, entry 51 in toys and childcare articles.
  • DEHP, DBP, BBP and DIBP are classified as SVHC under REACH.
  • DEHP, DBP and BBP are listed in REACH Annex XIV and are subject to further regulations due to their classification as Cat. 1B reproductive toxins.
Proposal for the restriction of phthalates
51a. The following phthalates (or other CAS and EC numbers covering the substance):

(a) Bis(2-ethylhexyl)phthalate (DEHP)
CAS No 117-81-7
EC No 204-211-0

(b) Dibutyl phthalate (DBP)
CAS No 84-74-2
EC No 201-557-4

(c) Benzyl butyl phthalate (BBP)
CAS No 85-68-7
EC No 201-622-7

(d) Diisobutyl phthalate (DIBP)
CAS No 84-69-5
EC No 201-553-2 		1. Articles intended for use indoors and articles that may come into direct contact with the skin or mucous membranes containing one or more of these phthalates in a concentration greater than 0.1 % by weight of any plasticised material shall not be placed on the market after (12 months from entry into force).

2. By way of derogation, paragraph 1 shall not apply to the immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC or Directive 2001/83/EC, or to medical devices covered under Directive 90/385/EEC, Directive 93/42/EEC or Directive 98/79/EC.

3. By way of derogation, paragraph 1 shall not apply to toys. By way of derogation, paragraph 1 shall not apply to childcare articles as regards DEHP, DBP and BBP.

4. By way of derogation, paragraph 1 shall not apply to articles intended to come into contact with food covered by Regulation (EC) No 1935/2004 and specific measures under this regulation, e.g. Commission Regulation (EU) No 10/2011.

5. By way of derogation, paragraph 1 shall not apply to articles intended for use indoors and articles that may come into direct contact with the skin or mucous membranes that were in use in the European Union before (date of entry into force).

6. For the purpose of this entry 'childcare article' shall mean any article intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children. 'Use' shall mean any placing, keeping, storing, hanging, laying, applying, mounting, fixing or other application indoors of articles.

Additional Information:
Annex XV report and consultation information along with a link to submit comments can be found at: http://echa.europa.eu/restrictions-under-consideration


Bureau Veritas Solutions and Services

Bureau Veritas offers a wide range of chemical management solutions to help you overcome the challenges of complying with this and other regulations. To find out how we can assist you in meeting a variety of requirements visit: www.bureauveritas.de/cps, www.bureauveritas.co.uk/cps, www.bureauveritas.fr/cps, or email: cps-hamburg@de.bureauveritas.com

Bureau Veritas Consumer Products Services, Inc. ("BVCPS") provides the information in this client bulletin as a resource of general information. It does not replace any applicable legal or regulatory requirements and is provided "as is." BVCPS will not be liable for any indirect, special, punitive, consequential or other damages (including without limitation lost profits) of any kind in connection with this client bulletin. BVCPS DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, IN CONNECTION WITH THIS CLIENT BULLETIN.


Copyright © 2011 Bureau Veritas Consumer Products Services, Inc. All Rights Reserved.