Modernization of EU chemicals legislation helps to strengthen preventive health and environmental protection 

(German) Federal Environment Ministry 7feb01

Berlin -- A fundamental revision of European chemicals legislation is about to take place. Pivotal to the planned amendment is a uniform assessment procedure for all chemical substances, enabling the risk potential of existing substances to be assessed more effectively. The legal changes will be based on a white paper on chemicals policy due to be adopted by the EU Commission. Federal Environment Minister Jürgen Trittin welcomed the planned amendment, which he felt would strengthen essential environmental and health protection. The next stage is to conduct a broad-based dialogue on these expedient proposals. With this in mind, the Minister is planning to hold a forum on 15 March in Bonn at which environmental and consumer organisations, the chemicals industry and the trade unions will be given the opportunity to express their opinions of the white paper.

Current EU legislation distinguishes between existing and new chemical substances, and imposes different requirements regarding the submission of material data. One serious shortcoming of the current system is that there is generally little or no information available about the risks to the environment and human health posed by over 100,000 existing substances placed on the market prior to 1981. The distinction between new and existing chemicals is due to be abolished by 2018 at the latest.

According to Federal Environment Minister Trittin, "It is high time that companies who circulate or import existing substances should be required to submit data to enable an assessment of their risk potential. Here, I see clear parallels to food safety. Untested chemicals can be just as dangerous as untested cattle. We cannot allow a repeat of the kinds of mistakes made as a result of our ignorance about DDT, asbestos and CFCs".

Trittin stressed that the planned new system would entail a reasonable level of expenditure and would not affect competition. "The fears being voiced by the chemicals lobby are completely exaggerated. Scare stories that 100,000 jobs in Germany and 400,000 jobs in the EU could be at risk as a result of this new ruling are wildly unrealistic."

Chemicals legislation - Background document to the EU paper on chemicals legislation

Background document

EU white paper on chemicals legislation

In future, all chemical substances within the EU are to be evaluated equally and their risk potential for man and the environment assessed according to a uniform procedure. In the medium to long term, the distinction between new and existing chemicals will be abolished.

The imbalanced treatment of existing and new substances has prompted fierce criticism within the EU. In June 1999, under the German Presidency, the EU Council of Environmental Ministers resolved to ask the EU Commission to submit a white paper on the comprehensive reorganization of EU chemicals policy.

At present, new chemical substances are subject to a registration procedure - in other words, anyone wishing to market more than 10 kilograms per annum of a substance must first register it with the responsible authority. For quantities in excess of 1 tonne per annum, a basic data record must be submitted to enable initial assessment of the environmental and health risks.

The initial objective is to ascertain any acute effects, such as toxicity for human health and the environment. When marketing quantities of more than 100 tonnes, studies must be carried out to assess any long-term adverse impacts such as carcinogenic or mutagenic effects. For existing substances, on the other hand, of which there are over 100,000, the only requirement is that available data must be submitted for quantities of 10 tonnes or more, which is not usually suitable for an adequate assessment of the substances. Only the 140 substances contained in EU priority lists required the submission of comprehensive data records. To date, this has only led to a conclusive assessment in four cases.

Pivotal to the Commission's proposal is the introduction of a new registration, assessment and approval procedure for all chemicals. By 2018 at the latest, all chemicals will be subject to a uniform system graded on the basis of time and volume. This will be based on the current registration procedure for new substances, but compulsory registration will only apply from a volume of 1 tonne or more, so that only 30,000 of the 100,000 existing substances will be covered. Evidence of animal testing will have to be submitted only for volumes of 10 tonnes or more. The assessment procedure to evaluate long-term effects, previously only valid for new chemicals, will apply to all substances with a volume of 100 tonnes or more. The new system will make it easier for industry to develop new substances and afford greater autonomy up to a volume of 100 tonnes, whilst at the same time allowing the authorities to concentrate on high-volume substances of 100 tonnes or more, which have greater relevance for environmental and consumer protection.

If a substance is found to have particularly hazardous properties, its continued use once a specified transitional period has elapsed is subject to approval. Under the new licensing procedures, the substance will be investigated in order to determine whether the planned use is sufficiently safe and acceptable despite its hazardous properties, with due regard for any intended safety measures on the part of the applicant and the intended application. This procedure will apply to substances with a carcinogenic, mutagenic or fertility-impairing effect. It will also be considered for substances with low biodegradability in the environment and which could therefore accumulate in the food chain.

In order to encourage innovation within the chemicals industry, companies are being granted additional concessions in the field of research and development. In particular, this concerns the current exemption from compulsory registration for new substances, which is being extended from one year to three years with the option of extending to a total of five years.

The new assessment procedure applies equally to EU producers, as well as manufacturers outside of the EU hoping to market their substances within the European Community.

The EU Council and the European Parliament will now be examining the EU Commission's white paper.