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EU Risk Assessments

The background

Substances on European priority lists must undergo an in-depth risk assessment covering the risks posed by the priority chemical to man (covering workers, consumers and man exposed via the environment) and the environment (covering the terrestrial, aquatic and atmospheric eco-systems and accumulation through the food chain). This EU risk assessment procedure was set up by the Council Regulation (EEC) 793/93 of 23 March 1993 on the evaluation and control of the risk of existing substances. It follows the framework set out in Commission Regulation (EC) 1488/94 and implemented in the detailed Technical Guidance Documents (TGD) on Risk Assessment for New and Existing Substances.

The principles

The risk assessment is the evaluation of the risk of a chemical to man and to his environment.

The risk depends on two factors: the intrinsic properties of the substance and the possibility of exposure.

Let us take an example: potassium cyanide is a very toxic product; this toxicity is part of its intrinsic properties. Now let us say the potassium cyanide locked in a safe, the key to which is lost.

In this example, there is no possibility of exposure, even though the substance is very toxic: there is a hazard, but there is no risk.

Substances under risk assessment: the procedures

On the base of the tonnage produced and on the already known properties of the chemical, and with additional regards to national priorities, the Commission publishes "Priority Lists". These lists comprise references of the chemical and a country that will take the lead in the dossier; this country is called the "Rapporteur". Four priority lists have been published until now; the last one was issued on October 26, 2001 in the Official Journal.

After the publication of a priority list, a delay of 6 months is given to the producers to collect all available data and reports on the substance, and to send this to the Rapporteur. After an evaluation, the Rapporteur identifies the gaps, and defines a timetable for the production of the missing data (normally 12 months).

The Rapporteur then issues a draft risk assessment report on which the industry may comment. After the comments are discussed, the Rapporteur generally issues a second draft, which is sent to the European Chemical Bureau (ECB). The ECB distributes the risk assessment report to all member states, which comment and discuss the issue during the Technical Meetings. There are four Technical Meetings a year.

The activities concerning the existing substances and the new substances have recently been merged, under the name "Technical Committee on New and Existing Substances" (TCNES).

Risk assessments and the Cefic Petrochemistry Industry Sector

Out of the 141 substances belonging to the four priority lists (abbreviated PL below), 32 are within the remit of the Cefic Petrochemistry Industry Sector:


Chemical PL Cefic Petrochemistry Industry Sector product group concerned
Acrylic acid1European Basic Acrylic Monomer Group
Acrylonitrile1Acrylonitrile Producers Association
Benzene1Aromatics Producers Association
1,3-butadiene1Lower Olefins Sector Group
2-butoxyethanol4Oxygenated Solvent Producers Association
2-butoxyethanol acetate4Oxygenated Solvent Producers Association
2-(2-Butoxyethoxy)ethanol1Oxygenated Solvent Producers Association
Cumene1Aromatics Producers Association
Cyclohexane1Aromatics Producers Association
2-ethoxyethanol2Oxygenated Solvent Producers Association
2-ethoxyethyl acetate2Oxygenated Solvent Producers Association
Ethyl acetoacetate1Oxygenated Solvent Producers Association
Ethylbenzene1Styrene Producers Association
2-ethylhexyl acrylate1Methacrylates (MMA + PMMA)
Methacrylic acid1Methacrylates (MMA + PMMA)
2-(2-Methoxyethoxy)ethanol1Oxygenated Solvent Producers Association
2-methoxyethyl acetate1Oxygenated Solvent Producers Association
1-methoxypropan-2-ol4Oxygenated Solvent Producers Association
1-methoxypropan-2-ol acetate4Oxygenated Solvent Producers Association
Methyl methacrylate1Methacrylates (MMA + PMMA)
Methyloxirane2Propylene Oxide & Glycols
Naphthalene1Coal Chemicals
Pentane2Hydrocarbon Solvent Producers Association
Phenol1Phenol Producers Association
Piperazine3Amines Sector Group
Pitch, coal tar, high-temp3Coal Tar Chemicals
Propan-1-ol2Oxygenated Solvent Producers Association
Styrene1Styrene Producers Association
Methyl-tert-butyl-ether3European Fuel Oxygenates Association
Toluene2Aromatics Producers Association
2,4,4-trimethylpentene2Lower Olefins Sector Group
Vinyl acetate1Acetyls Sector Group
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