why is there a concern over phthalates in school supplies?

Phthalates used as plasticizers in products for children, such as toys and childcare articles, have been of concern. Following assessment of the risks under Regulation (EEC) 793/93 on the evaluation and control of the risks of existing substances1, and the evaluation of CSTEE and SCHER of such assessments 2,3,4,5,6,7,8, Directive 2005/84/EC of the European Parliament and of the Council of 14 December 2005 prohibits the marketing and use of the following phthalates9:

– Bis (2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP) and benzyl butyl phthalate (BBP) in all toys and childcare articles;

– Di-isononyl phthalate (DINP) and di-isodecyl phthalate (DIDP) in toys and childcare articles which can be placed in the mouth by children.

A further plasticizer, di-n-octyl phthalate (DNOP), was banned from toys and childcare articles which can be placed in the mouth by children on the basis of a CSTEE evaluation on the risks of phthalates in general10.

[1 OJ L 84, 5.4.1993, p. 1.
2 Opinion on Phthalates in Toys, SCTEE, 24 April 1998.
3 Opinion on Phthalate Migration from Soft PVC Toys and Childcare Articles, 6th SCTEE plenary meeting, 26/27 November 1998.
4 DINP: Opinion on the results of the Risk Assessment of: 1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich and di-"isononyl" phthalate. Report version (Human Health Effects), 27th CSTEE plenary meeting, Brussels, 30 October 2001.
5 DEHP: Opinion on the results of the Risk Assessment of Bis (2-ethylhexyl) phthalate (DEHP). Report versions: Environment / Human Health, September 2001. Opinion expressed at the 29th CSTEE plenary meeting, Brussels, 09 January 2002.
6 DIDP: Opinion on the results of the Risk Assessment of: 1,2-Benzenedicarboxylic acid di-C9-11-branched alkyl esters, C10-rich and di-"isodecyl"phthalate - Report version (Human health effects): 24th CSTEE plenary meeting, Brussels, 12 June 2001.
7 DBP: Opinion on the results of the risk assessment Report of DIBUTYLPHTHALATE, 23rd CSTEE plenary meeting, Brussels, 24 April 2001.
8 BBP: Scientific Committee on Health and Environmental Risks opinion on: Risk Assessment Report on Benzyl Butyl Phthalate (BBP) Human Health Part CAS No.: 85-68-7 EINECS No.: 201-622-7. Adopted by the SCHER during the 3rd plenary meeting of 28 January 2005.
9 OJ L 344, 27.12.2005, p. 40.
10 See: Opinion on Phthalate Migration from Soft PVC Toys and Childcare Articles, 6th SCTEE plenary meeting, 26/27 November 1998.]

Study of the Danish Environmental Protection Agency

The Danish Environmental Protection Agency (EPA) has recently analysed phthalates in school supplies such as school bags, play bags, pencil cases and erasers. In addition, the Danish EPA identified DEHP (and small amounts of DBP) in a pencil case. It furthermore found phthalates, without identifying them individually, when screening other school supplies such as pencil cases, toy bags and school bags.

The Danish EPA concluded that “In general, the content of the above-mentioned substances [isophorone, Butylated hydroxytoluene, cyclohexanone, phenol, toluene, DIBP, DEHP, 2-heptanone, tert-butyl alcohol, methyl propionate, p-xylene] in the tested products does not present any health risk at normal use of the products; neither in the individual products nor if children are exposed to several products at once - for instance through use of pencil case, eraser and school bag - at exposure via both inhalation and migration for artificial sweat".

However, "Some of the studied erasers are made of PVC (9 of 26) and four of these erasers have a content of DEHP as plasticizer. Daily intake of a small amount (cube of approx. 4 mm) of eraser with a content of DEHP during a longer period may represent a health risk. Correspondingly, it may represent a health risk if a child daily sucks on an eraser with a high content of DEHP during a longer period.", and)”, "The calculations are generally based on the analyzed values for a few selected school bags, toy bags, pencil cases and erasers. It cannot be excluded that there may be products with a higher content than found in the products tested in this project. Furthermore, there may be other sources to the same chemical substances in the child’s surroundings which will contribute to the total exposure."

For an additional plasticizer identified in the school supplies but not covered by Directive 2005/84/EC, Di-isobutyl phthalate (DIBP), the Danish EPA considered that "All the calculated MOS [Margins of Safety] of the individual products are significantly above 100 and this assessment is thus they do not represent any health risk with regard to DIBP. Exposure to DIBP both by inhalation and through skin absorption from several products at the same time is not estimated to represent any health risk for the examined products."

Finally, in a separate assessment of DINP, the Danish EPA concludes that "the exposure to phthalates through erasers is unacceptable."

Separate from the Danish study, there are claims that phthalates other than those banned are used in consumer products, however without sufficient knowledge about their risks. Although such claims are unconfirmed so far, it appears plausible that such phthalates may be used in order to avoid a conflict with the ban.

http://ec.europa.eu/health/opinions/en/phthalates-school-supplies/l-3/1-concern.htm#0p0

Factual links
1. Information on health risks due to phthalates in school supplies

The Danish Environmental Protection Agency published the results of a study analysing the possible harmful impacts from substances being emitted from school bags, toy bags, pencil cases and erasers. The summary and the full study are available at:
www.mst.dk/Udgivelser/Publications/2007/08/978-87-7052-547-3.htm
The opinion by the European Commission Scientific Committee on Health and Environmental Risks (SCHER) on phthalates in school supplies assessing the Danish study on this topic is available at: http://ec.europa.eu/health/ph_risk/committees/04_scher/docs/scher_o_106.pdf

2. Links addressing phthalates and health risks to children

The European ban of the use of six phthalates in soft PVC toys and childcare articles by a Commission decision in 1999 followed by a directive in 2005. More information at:
http://ec.europa.eu/scadplus/leg/en/lvb/l32033.htm
The European Commission issued a guidance document on the interpretation of the concept “which can be placed in the mouth”, which is often referred to in risk assessments of phthalates in toys and childcare products:
http://ec.europa.eu/enterprise/chemicals/legislation/markrestr/guidance_document_final.pdf
Upon request by Directorate General Enterprise of the European Commission a report on "The Availability of Substitutes for Soft PVC Containing Phthalates in Certain Toys and Childcare Articles" was prepared by RPA Ltd. in association with the Research Institute for Toxicology (Utrecht University). The report is available at: www.rpaltd.co.uk/documents/phthalates_000.pdf
Opinions of the E.U. Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE):
1998 opinion on "Phthalate migration from soft PVC toys and child-care articles", available at:
http://ec.europa.eu/comm/health/ph_risk/committees/sct/documents/out12_en.pdf
2001 opinion on the RPA Report on "The Availability of Substitutes for Soft PVC Containing Phthalates in Certain Toys and Childcare Articles", available at:
http://ec.europa.eu/health/ph_risk/committees/sct/docshtml/sct_out92_en.htm
The Canadian government has taken actions to increase the safety of consumers, especially children with regard to the presence of phthalates. More information at:
www.chemicalsubstanceschimiques.gc.ca/interest-interet/phthalates_e.html

3. Institutions addressing phthalates in general

The formerly known European Chemicals Bureau (ECB) published risk assessment reports on several phthalates including five of the most widely used ones: DEHP, DBP, DIDP, DINP and BBP. Summaries by GreenFacts are available at: www.greenfacts.org/en/digests/phthalates.htm
The opinions of the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) on the results of the ECB risk assessment of different phthalates are posted at:
http://ec.europa.eu/health/ph_risk/committees/sct/sct_opinions_en.htm
for DEHP
for DINP
for DIDP
for DBP
The European Commission published two communications on phthalates in 2006:
on risk reduction measures for different phthalates
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:104:0045:0047:EN:PDF
on the results of the risk evaluation and the risk reduction strategies for those substances:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2006:090:0004:0028:EN:PDF
The Panel on food additives, flavourings, processing aids and materials in contact with food (AFC) of the European Food Safety Authority (EFSA) gives its opinion on the use of the phthalate DEHP in food contact materials at: www.efsa.europa.eu/EFSA/ScientificPanels/AFC/
for DBP
for DIDP
for DINP
for DEHP
for BBP
The Danish Veterinary and Food Administration (DVFA) published a report in 2003 on "Human exposure to selected phthalates in Denmark”:
http://gl.foedevarestyrelsen.dk/FDir/Publications/2003015/Rapport.pdf
The U.S. Center for Disease Control and Prevention (CDC) provides general information on phthalates and more specific information on different kinds of phthalates at:
www.cdc.gov/exposurereport/results_06.htm