Little Pro on 2016-07-17

Phthalates are a group of chemical substances used to soften plastics. They are also called plasticizers and can be found in many articles and consumer products. Some phthalates have shown adverse effects on reproductive system and endocrine system. In this article, we will summarize known phthalate restrictions in articles and consumer products in EU and other countries. 

Phthalates and REACH Annex XVII

Phthalates are included in REACH Annex XVII restricted substances list (entry 51 and 52). Currently 6 phthalates are restricted in plasticised material in toys and childcare articles. The restriction conditions are listed as follows:

Substance Product Limit
  • Bis (2-ethylhexyl) phthalate (DEHP) 
  • Dibutyl phthalate (DBP) 
  • Benzyl butyl phthalate (BBP)
 Use in PVC and other plasticized materials in all toys and childcare articles.  DEHP+DBP+BBP<=0.1% 
  •  Di-‘isononyl’ phthalate (DINP) 
  •  Di-‘isodecyl’ phthalate (DIDP) 
  • Di-n-octyl phthalate (DNOP)
 Toys and child care articles which can be placed in the mouth by children  DINP+DIDP+DNOP<=0.1% 

Phthalates and REACH Annex XVII

Phthalates and EU RoHS 2

On 4 June 2015, the EU commission has published a new Directive (EU) 2015/863 to amend Annex II to EU RoHS 2 (Directive 2011/65/EU) to add the following 4 phthalates onto the list of restricted substances under EU RoHS 2.

  • Bis(2-Ethylhexyl) phthalate (DEHP): <= 0.1%;
  • Benzyl butyl phthalate (BBP): <= 0.1%;
  • Dibutyl phthalate (DBP): <= 0.1%;
  • Diisobutyl phthalate (DIBP): <= 0.1%.

DEHP, BBP, DBP and DIBP will be restricted from 22 July 2019 for all electrical and electronic equipment apart from Category 8 (medical devices) and Category 9 (monitoring and control equipment) that will have an additional two years to comply by 22 July 2021.

Phthalates Restrictions in USA

US Consumer Products Safety Improvement Act (CPSIA) has also banned 6 phthalates in children's toys and child care articles. The restriction limits are listed as follows:

Product Limit
Children's toys and child care articles. DEHP, DBP, BBP<=0.1% 
Any children's toythat can be placed in a child's mouth and child care articles. DEHP, DBP, BBP, DINP, DIDP, DNOP<=0.1% 

It should be noted that DEHP, BBP, DBP, DIDP are also on California Proposition 65 list. The State of California require manufacturers of articles and consumer products (including non-toys and non-childcare products) containing listed chemicals to place "reasonable warnings" on product packaging to alert purchasers. 

Phthalates Restrictions in Other Countries

Country Restrictions
  • DBP, DEHP or BBP<= 0.1% in the plasticized material in designated toys;
  • DIDP, DINP or DNOP<=0.1% in the plasticized material in the parts that are intended to be placed in the mouth (excluding pacifiers and teething rings);
  • For toy that are intended to come in contact with infant’s mouth, PVC parts that are not intended to come in contact with infant’s mouth shall not use DINP as raw material.


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 Tags: Topics - RestrictionSubstance Restriction in Articles