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anses

French Agency for Food, Environmental and Occupational Health & Safety

ANSES proposes that THFA be classified as a suspected reproductive toxicant

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News of 07/12/2011

7 December 2011

What is tetrahydrofurfuryl alcohol?
Tetrahydrofurfuryl alcohol (THFA) is an organic compound used as a solvent in many applications and products intended for both professionals (a chemical intermediate in the chemical and pharmaceutical industries, a solvent in pesticides) and consumers. It is used as a cleaning product, stripping compound and in dyes and finishes for textiles and leather. It is currently considered, at European level, as an irritant to the eyes(1).
What are the hazards of THFA?
The literature review conducted by ANSES has found that THFA induced testicular impairment, characterised by testicular atrophy, which may be associated with impaired sperm production in male rats that have been exposed via an oral, dermal or inhalation route for 28 days or more. A direct effect on fertility has not been established but the existing studies were not considered to be conclusive enough to rule out these effects.
Furthermore, after exposure of female rats during mating, gestation and lactation, an increased incidence of foetal loss and pup mortality at birth were observed. However, these effects occurred at doses inducing maternal toxicity, which may also be partly responsible for the developmental effects observed. Nevertheless, decreased pup weight was also observed at a dose that was non-toxic to the mothers exposed only during gestation.

Should it be classified as toxic to reproduction at European level?
In this context, ANSES - as the agency responsible for providing support to the French authorities for the implementation of European regulations on the labelling of chemicals - prepared and submitted a proposal on behalf of the French authorities in December 2010, to revise the THFA classification in order to take this hazard into account at European level. The French proposal would classify THFA as a substance suspected of being toxic to reproduction (2), for its effects on fertility and the development of offspring, in addition to the current existing classification for eye irritation.
If this classification were adopted, it would, in particular, have the effect of requiring that THFA's reproductive toxicity be taken into account when applying general rules for the prevention of chemical risks in the workplace(3). As another example, this substance could not (without a specific waiver) be used in cosmetic products.
The next steps
Initially, this proposal will be put forward for public consultation on the ECHA website to give all stakeholders an opportunity to present their positions, scientific arguments or any additional information that they have at their disposal. This public consultation will be open for 45 days.
It began on 25 November 2011 and will end on 9 January 2012.
When this consultation phase has been completed, experts from ECHA's Risk Assessment Committee will examine the French proposal and the comments received during the consultation. This will mainly involve studying the proposal with respect to the European classification criteria and the scientific evidence, in order to rule collectively on the classification to be adopted.
Based on the work of this committee, ECHA will issue a final opinion, which will be sent to the European Commission within 18 months of publication of the proposal. The Commission will then decide whether or not to change the classification of tetrahydrofurfuryl alcohol or THFA (4).

Find out more:

How does the classification of chemicals change at the European level?

Two regulations govern chemicals at the European level, in general:

The REACh regulation, which establishes the rules for registration, evaluation and authorisation of chemicals, and the CLP Regulation, which determines the criteria and procedures for their classification, labelling and packaging. This second text stipulates that the hazards of the chemicals and mixtures be established when they are first placed on the market. Based on the identified hazards, the substances are then classified and, where appropriate, subject to specific labelling to inform and protect workers and consumers, which might also include measures governing their use. Whenever new scientific data are likely to change a substance's classification, a Member State may submit a proposal to amend the classification to the European Chemicals Agency (ECHA), the body responsible for the implementation of the REACh and CLP Regulations. ECHA then consults all stakeholders. When the consultation is over, it then prepares an opinion for the European Commission, which is ultimately responsible for determining whether or not to change the substance's classification. It is in this context that France has proposed a change to the classification of tetrahydrofurfuryl alcohol or THFA (5).

> The opinion of 30 November 2011(in french)

(1) Eye Irrit. 2 - H319 according to the CLP
(2) Repr 2 - H361fd according to the CLP
(3) Articles R. 4412-1 to R. 4412-58 of the French Labour Code
(4) CAS 97-99-4
(5) CAS 97-99-4