Some questions you may be asking ...
The EU Technical Progress Committee (TPC) met in Brussels on January 25, 2001 and voted to accept a recommendation by the EU Classification and Labelling Working Group that DEHP be classified as category 2 for fertility and developmental effects.
1. What does a category 2 classification mean and what has been the impact?
A category 2 classification means that the substance, when packaged or stored, has to be labelled with a skull and crossbones symbol. However, it should be remembered that this is a symbol of potential hazard and not of risk. The classification is intended to provide guidelines for safe handling during "occupational use" (use at production sites and processing facilities). There is no requirement to label finished articles containing the phthalates and neither is there any suggestion that the continued use of such phthalates in finished articles is unsafe.
A category 2 classification also restricts substances to professional use only. i.e. they cannot be sold in their original form, or as a mixture containing the substance, directly to members of the public. As phthalates as such are not sold to members of the general public anyway this has had little impact on previous business practices.
2. Does this mean that manufacturers of products containing DEHP now have to label
them with the skull and crossbones?
Finished PVC products - such as flooring, cable, sheeting etc, are "articles" and are therefore not required to be labelled.
Labelling is only required for the actual substance itself or preparations such as plastisols before eventually being used in a finished article. Such substances or preparations are labelled as restricted to "professional use" meaning that they cannot be sold to the general public.
3. Does this new legislation mean that articles and consumer products can no longer
be made using DEHP?
No it does not mean that they are forbidden or restricted in finished articles. DEHP has been widely used in consumer goods for more than 50 years and can continue to be safely used in such products.
There has been considerable confusion among peopel thinking that it can no longer be used simply because the substance itself has been labelled and must no longer be sold to the general public in liquid form. A letter from the European Commission to ECPI makes it perfectly clear that the restrictions do not apply to finished goods. Please note that the letter refers specifically to automotive parts because of concern that had been expressed by an automotive manufacturer but it applies equally to any finished articles.
4. On what basis was the decision made?
The decision was based on toxicological evidence found during tests on rodents.
However, in order for any adverse effects to become evident the studies have to be conducted over prolonged periods and at extremely high exposure levels - many times higher than is experienced on a daily basis in the workplace.
According to the Classification and Labelling guidelines, the relevance of rodent based data on phthalates to man needs to be critically evaluated. ECPI is conducting further studies to clarify this point. It is regrettable that the Classification and Labelling Working Group made its recommendations without waiting for the outcome of these studies.
5. When does this classification take effect?
EU Member States were given until July 30, 2002 to adopt the legislation.
6. If the new studies subsequently clarify that the effects are indeed only relevant to
rodents and not to humans is there an opportunity to relabel?
The EU is obliged to look again at any classification made if new evidence becomes available.
When Member States met to discuss the proposal for a category 2 classification in May 2000, some expressed concerns regarding the relevance of the existing data to man. A number of Member States also considered this to be a borderline case between a category 2 or 3 classification.
When the results of new studies to clarify the relevance to humans become available we would therefore expect it reconsidered as a matter of priority.
7. Classification as Category 2 impacts on worker safety. Do manufacturers have to
put in place new standards so as to protect workers?
Most if not all the requirements from an EU perspective were already being met.
For many years industry had classified DEHP as a category 3 substance for possible fertility and developmental effects. Respective measures for occupational protection therefore had to be already implemented. Whether additional country-specific restrictions have to be respected needs to be clarified in each Member State.
8. Do employers have to substitute DEHP?
For substances in categories 2 and 3 the Chemical Agents Directive 98/24 and Directive 92/85 EEC requires employers to carry out a risk assessment and identify such measures as personal protection and ventilation that may be required. Only if these measures do not help to comply with the occupational limits, other measures such as a change of production procedures or even substitution have to be considered.
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