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French Agency for Food, Environmental and Occupational Health & Safety

Phthalates, parabens, alkylphenols: four questions for Marc Mortureux

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News of 05/05/2011

5 May 2011

Assessing the risks associated with endocrine disruptors - chemicals such as phthalates, parabens and alkylphenols - is a key priority for ANSES. Marc Mortureux, Director General of ANSES, comments on the issue, which is currently being debated in Parliament, and gives an update on the progress of ongoing work.

1 / What exactly are phthalates, parabens and alkylphenols?

Phthalates are plasticisers used mainly for the manufacturing of PVC (polyvinyl chloride) to which they add the required flexibility (rigid, semi-rigid or flexible) and facilitate its shaping. They can also be used in the manufacture of many other products (paints, varnishes, adhesives, sealants, lacquers, inks, household products, plant protection products, etc.) and by the rubber, photography, paper and cardboard, timber, construction materials and automotive industries. They are therefore found in hundreds of common consumer items and products such as adhesives, vinyl flooring, lubricating oils, electrical capacitors, detergents, electrical cables and cosmetics (perfumes, deodorants, aftershave lotions, shampoos, hair sprays, nail polishes, etc.).
Parabens are substances with antibacterial and antifungal properties, widely used as preservatives in cosmetics (shampoos, moisturising creams, shaving foams, etc.), drugs and foods (as food additives). They can also be used as preservatives in tobacco products and some household products (detergents), and are used in the manufacture of varnishes, glues, adhesives and polishes.
Alkylphenols are used in the manufacture of adhesives, paints, emulsion floor polishes, household cleaning fluids, in the leather industry, in polishing compounds, felt automobile gaskets, in building materials, in pulp and paper, in the textile industry, in post-surgical plaster, in the timber industry and as preservatives in laundry starch. They are also active ingredients in the formulation of industrial and household disinfectants (sprays, wipes) and disinfectants for the medical sector.

2 / What are the risks and how are they regulated?

Some have or are suspected of having endocrine disruption effects. Studies conducted in animals, particularly in rodents, have indeed reported effects on male and female reproductive systems, on sperm production and quality and sometimes on fertility and the development of hormone-dependent cancers. However, there are still too few epidemiological studies currently available to be able to draw any conclusions about the impact of these compounds on humans.
In addition, it must be stressed that these three classes of compounds cover a huge number of substances with widely differing hazard levels and an extensive range of uses. Given this diversity, the levels of exposure to these substances and the risks they may pose vary greatly.

As far as regulations are concerned, several of the substances are covered by the European REACh Regulation (1) and the CLP Regulation (2), as well as by different texts that are specific to their uses (directive on toys, regulations on food contact materials, regulations on food additives, cosmetics, medical devices, etc.).

Accordingly, nine phthalates are classified as 1B reprotoxics under the CLP Regulation and a procedure is underway to obtain the same classification for a tenth substance. The six phthalates of greatest concern (DEHP, DBP, BBP, DINP, DODP and DIDP) are already subject to a European restriction procedure that will prohibit their use in toys and childcare items; these restrictions will be updated before the summer. All uses of the first three (DEHP, DBP and BBP) will be prohibited as of 2015, unless specific authorisation is granted on a case-by-case basis by the European Commission. The others are being evaluated in order to identify them as substances of high concern and add them to the list of substances subject to provisional and restrictive authorisation pending the introduction of substitute products.
Two alkylphenols are also subject to a restriction procedure and cannot be used or marketed as a substance or constituent of preparations at concentrations equal to or greater than 0.1% by weight for cleaning applications, textile and leather treatment (3), as an emulsifier in agricultural teat dip products, for machining metal (4), for the manufacture of pulp and paper, in cosmetics and other personal care products except spermicides, or, lastly, as coformulants in pesticides and biocides.

3 / Are there alternatives to these substances?

These three classes of compounds are very different with respect to the substances, levels of hazard they may pose, and uses. For many of them, data on existing substitutes are not currently available. In this context, it is important to recall that substitutes that may be used in an emergency can be as hazardous as the original, if not more so. Therefore, among these three classes, it is important to identify the substances of greatest concern, their uses and the existing substitutes, as well as the risks posed by the alternatives, in order to be able to substitute them safely.

4 / What does ANSES do with respect to these substances?

Besides its European activities relating to these classes of substances under the REACh and CLP regulations, ANSES is responsible for providing the competent authorities with the necessary expertise and scientific and technical support for the assessment of chemicals and the risks they pose to humans.

On the specific issue of bisphenol A, another substance suspected of having endocrine disruption effects, the Agency conducted five expert assessments in 2010, including the publication of three opinions, and within this framework issued a series of recommendations aimed at:

  • reducing population exposure, particularly for the most susceptible population groups;
  • improving consumer information, through the introduction of systematic labelling of domestic utensils and containers containing bisphenol A that may be in contact with food, to avoid them being overheated during use;
  • encouraging manufacturers to develop substitutes to bisphenol A for food use.

Finally, in a broader context, in 2009 the Ministry of Health formally requested AFSSAPS, AFSSA (5), AFSSET (5), the InVS and INPES to investigate the issue of endocrine disruptors in their respective fields of competence. INSERM, for its part, was commissioned to undertake a collective expert assessment on the effects of substances known as "endocrine disruptors" by collecting and analysing all the available scientific literature. On the basis of the substances identified as of concern for their reproductive toxicity and/or endocrine disruption action, the Agency is working on fifty substances, including around twenty phthalates, parabens and alkylphenols. For each of these, the work involves describing the hazards, identifying the uses and evaluating exposure of the population in order to assess the risks. One objective of this work is ultimately to identify possible substitutes for products or substances for which a health risk has been highlighted, and to ensure that these candidates for substitution have undergone risk assessment prior to their authorisation.
This work will continue over several years and will give rise to a series of risk assessment reports, each specific to a substance. The first report will be issued in 2011 and will focus specifically on bisphenol A. Reports dealing with other substances will be published from 2012 onwards.

Find out more

(1) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC.
REACh stands for Registration, Evaluation and Authorisation of Chemicals".

(2) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
CLP stands for Classification, Labelling and Packaging.

(3) except for treatments that do not involve discharges into waste water, and systems involving special treatments whereby the water is pre-treated to completely remove the organic component prior to biological wastewater treatment (degreasing of sheepskin).

(4) except for use in controlled closed systems in which the washing liquid is recycled or incinerated.

(5) AFSSA and AFSSET merged to form ANSES on 1 July 2010.