Toys

Plasticiser (US: plasticizers) have been used for decades to make toys soft, flexible and safe by replacing or protecting sharp edges and avoiding brittleness which could result in a choking hazard. The use of some orthophthalates has been restricted in the European Union since December 1999. In 2005 the temporary restrictions were formalised in the Marketing and Use Directive which in turn was incorporated into Annex XVII of REACH. DEHP, DBP and BBP are restricted in all toys and childcare articles based on their reproductive properties. DINP, DIDP and DNOP are restricted in toys and childcare articles which can be placed in the mouth based on ECHA and RAC not being able to exclude a risk (due to mild liver effects seen at high doses in rat studies).

The precise restrictions can be found in REACH Annex XVII (Paragraphs 51 and 52).

A childcare article is defined as “any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children”. The European Commission has produced a guidance document on the interpretation of the concept "which can be placed in the mouth."

Restrictions Re-evaluation

In January 2014, the European Commission published its conclusions on the re-evaluation of the restrictions on DIDP and DIDP indicating that “no unacceptable risk has been characterised” for the uses of these two non-classified high orthophthalates in articles other than toys and childcare articles which can be placed in the mouth”. The Commission therefore concluded that the existing restriction of DINP and DIDP in toys and childcare articles which can be placed in the mouth should be maintained (the precautionary restriction has been in place since 2005). The Commission further concluded that “in the light of the absence of any further risks from the uses of DINP and DIDP, the evaluation of potential substitutes has been less pertinent". DINP and DIDP are therefore safe for use in all current consumer applications – no further restrictions were proposed.

Based on the precautionary principle, current legislation limits the use of non-classified high phthalates di-isononyl phthalate (DINP), di-isodecyl phthalate (DIDP) and di-n-octyl phthalate (DNOP) which cannot be used as substances or as constituents of preparations, at concentrations of greater than 0,1 % by mass of the plasticised material, in toys and childcare articles which can be placed in the mouth by children. Such toys and childcare articles containing these phthalates in a concentration greater than the limit mentioned above shall not be placed on the market.

On the other hand, classified low phthalates plasticisers  Di (2-ethylhexyl) phthalate (DEHP), di-n-butyl phthalate (DBP) and butylbenzyl phthalate (BBP) shall not be used as substances or as constituents of preparations, at concentrations of greater than 0,1 % by mass of the plasticised material, in any toys and childcare articles. Such toys and childcare articles containing these phthalates in a concentration greater than the limit mentioned above shall not be placed on the market.

The Complete text of Directive 2005/84/EC of the European Parliament and of the Council of 14 December 2005 amending for the 22nd time Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles) is available in all official EU languages.

A childcare article is defined as “any product intended to facilitate sleep, relaxation, hygiene, the feeding of children or sucking on the part of children”. The European Commission has produced a guidance document on the interpretation of the concept "which can be placed in the mouth."

Relevant documents:

• European Parliament decision, 2nd reading T6-0266/2005
• Council common position 5467/1/05
• Council political agreement, PRES/04/269
• European Parliament opinion, 1st reading, OJ C121 p.410-413 & 414
• European Parliament Committee report, 1st reading A5-0149/2000
• European Social Committee opinion ESC/2000/243
• Commission Proposal COM(99)577

Restrictions Re-evaluation

In January 2014, the European Commission published its conclusions on the re-evaluation of the restrictions on DIDP and DIDP indicating that “no unacceptable risk has been characterised” for the uses of these two non-classified high phthalates in articles other than toys and childcare articles which can be placed in the mouth”. The Commission therefore concluded that the existing restriction of DINP and DIDP in toys and childcare articles which can be placed in the mouth should be maintained (the precautionary restriction has been in place since 2005). The Commission further concluded that “in the light of the absence of any further risks from the uses of DINP and DIDP, the evaluation of potential substitutes has been less pertinent". DINP and DIDP are therefore safe for use in all current consumer applications – no further restrictions were proposed.