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European chemicals legislation REACH must be consumer-friendly

21/2005, 28.06.2005

BfR calls for improvements to the test concepts, consumer information and use of alternative test methods in the REACH proposal

"REACH will very much shape the level of consumer safety of chemicals and products in Germany, too, over the next 20 years," said Professor Dr. Dr. Andreas Hensel at the first BfR Consumer Forum in Berlin. "Anything that isn’t anchored now in the draft regulation," commented Hensel, "will not be taken into account over the next few years either". That’s why the Institute is calling for noticeable improvements to consumer protection in REACH prior to the reading of the proposal in the European Parliament in October of this year. Since the submission of the White Paper in 2001, BfR has been defending consumer protection in European chemicals legislation. The main thrust of its demands: more comprehensive evaluation of consumer chemical products, the obligation to make priority use of test methods and test strategies involving no animal experiments as well as major improvements to consumer information.

Around 200 experts from public authorities, government, science, industry and associations came together to discuss the position of consumer protection in the current proposal of the new European chemicals legislation, REACH, at the first BfR Consumer Protection Forum on 23 and 24 June. One of the three critical themes focussed on questions relating to substance assessment. In contrast to manufacturers and processors of chemicals, consumers come into contact with substances in a wide range of products and articles. This is where the Institute believes the proposal has major shortcomings. The Institute is, therefore, calling for a minimum data set for all chemicals used in consumer products for the purposes of assessing potential risks to health. Priority is to be given to information on carcinogenic, mutagenic and reprotoxic properties.

Besides information on the harmfulness of a substance, data on consumer exposure to chemicals is required for the assessment of the health risk. BfR assessments have shown that when handling products contact is not normally short but that the burden is longer-lasting. Substances also reach consumers from the air, water or food as they are released into the environment during production and further processing. Both types of exposure are cumulative and must be taken into account when assessing the risk. BfR, therefore, proposes a systematic classification of substances and preparations in so-called "use and exposure categories". This is to facilitate the assessment of contact opportunities with chemicals. For instance the consumer may come into account with acetone in around 450 products. Acetone may also be found in air, water and food as a consequence of processing. Evaluation limited to a single product underestimates the consumer’s exposure. An appropriate assessment of the risk from substances must take the exposure to various consumer products as well as exposure through production-related release into air, water and food into account.

BfR is, therefore, in favour of stipulating the use of alternative test methods and intelligent test strategies to a greater degree in REACH. The objective must be to obtain basic information solely through methods involving no animal experiments which should also include cytoxicity determination in mammalian cells. For all further data as few animals as possible should be used. Besides drawing on recognised methods involving no experimental animals, this can also be done by means of intelligent test strategies using smaller numbers of animals. Furthermore, BfR is calling for data, that has been obtained by industry using alternative test methods and has been used up to now exclusively for internal purposes, to be made accessible for independent assessment. This would speed up the recognition of test methods involving no animal experiments and improve their acceptance rate.

In order to guarantee consumer protection through REACH, consumers must be supplied with easily understandable information. Consumers must be well enough informed about actual or suspected risks in order to take important decisions themselves when choosing products. Since consumers tend to come more into contact with products than pure substances, safety data sheets for chemical substances are not suitable for product labelling. Hence, BfR suggests developing consumer-friendly labelling.

“As a consequence of the medical notification obligation for intoxications in accordance with chemicals legislation, important substance information is collected in Germany which should definitely be input into REACH,” demands Hensel. The Institute is also in favour of independent risk communication in the new chemicals legislation in order to improve the effectiveness and transparency of the assessment process for consumers. In this context BfR adopts the stance that the certainty and uncertainty of risk assessment and also of management decisions should be conveyed to consumers. Moreover, the Institute criticises the fact that REACH does not stipulate whether and, if so, how the information is to be conveyed to the consumer. Unnecessary confidentiality provisions must, therefore, be dismantled and “data cemeteries” avoided. More information on the BfR positions and on this event can be accessed on www.bfr.bund.de, Veranstaltungen (Events) (in German).

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