EU Risk Assessment

The European Commission has confirmed that Diisodecyl phthalate (DIDP) poses no risk to either human health or the environment from any current use.

The European Commission published its findings in the EU Official Journal on April 13 2006, confirming the outcome of a risk assessment involving more than 10 years of extensive scientific evaluation by EU regulators (please see press release).

Following the recent adoption of EU legislation with the regard to the marketing and use of DIDP in toys and childcare articles, the risk assessment conclusions clearly state that there is no need for any further measures to regulate the use of DIDP.

The rigorous EU risk assessments, which include a high degree of conservatism and built-in safety factors, have been carried out under the strict supervision of the European Commission and provide a clear scientific evaluation on which to judge whether or not a particular substance can be safely used.

"After such a resounding regulatory approval from the European Union, downstream users can continue to use DIDP with the utmost confidence" said Dr David Cadogan, Director of the European Council for Plasticisers and Intermediates (ECPI). "Once the REACH legislation enters into force, the conclusions of the risk assessments and the body of research that underpin them will be of great assistance to both producers and users of these substances."

The final Summary and Full EU Risk Assessment reports on DIDP have been published by the European Commission's European Chemical Bureau (ECB).

Before publication in the EU's Official Journal, the final reports require endorsement by the EU Member States Article 15 Committee.

The Risk Assessment was carried out in accordance with Council Regulation (EEC) 793/931 on the evaluation and control of the risks of "existing" substances.

"Existing" substances are chemical substances in use within the European Community before September 1981 and listed in the European Inventory of Existing Commercial Chemical Substances. Regulation 793/93 provides a systematic framework for the evaluation of the risks to human health and the environment of these substances if they are produced or imported into the Community in volumes above 10 tonnes per year.

There are four overall stages in the Regulation for reducing the risks: data collection, priority setting, risk assessment and risk reduction.

Data provided by Industry are used by Member States and the Commission services to determine the priority of the substances which need to be assessed. For each substance on a priority list, a Member State volunteers to act as "Rapporteur", undertaking the in-depth Risk Assessment and recommending a strategy to limit the risks of exposure to the substance, if necessary. The DIDP risk assessment was conducted by France.

The methods for carrying out an in-depth Risk Assessment at Community level are laid down in Commission Regulation (EC) 1488/942, which is supported by a technical guidance document.

Normally, the "Rapporteur" and individual companies producing, importing and/or using the chemicals work closely together to develop a draft Risk Assessment Report, which is then discussed and agreed at Meetings of Member State technical experts.

The Risk Assessment Report is then peer-reviewed by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE) which gives its opinion to the European Commission on the quality of the risk assessment.

If a Risk Assessment Report concludes that measures to reduce the risks of exposure to the substances are needed, beyond any measures which may already be in place, the next step in the process is for the "Rapporteur" to develop a proposal for a strategy to limit those risks. In the case of DIDP, the only identified risks are hypothetical so the rapporteur is suggesting no further risk reduction measures.

The Risk Assessment Report is also presented to the Organisation for Economic Co-operation and Development as a contribution to the Chapter 19, Agenda 21 goals for evaluating chemicals, agreed at the United Nations Conference on Environment and Development, held in Rio de Janeiro in 1992.

The purpose of a Risk Assessment is to improve knowledge about the risks to human health and the environment from exposure to chemicals and to help meet the European Community objective of reducing the overall risks from exposure to chemicals.

For further information please also see the advertisements and advertorials which have been placed in specialist media by the European Council for Plasticisers and Intermediates.