Často kladené otázky o legislativě REACH

Why do we need new legislation on chemicals?
We are exposed to hundreds and maybe even thousands of industrial chemicals every day. Chemicals are present in just about everything we use at home, including cleaning materials, clothes, cosmetics, furniture, packaging and even toys. Yet the vast majority of these chemical ingredients have not been properly tested for safety. This is because, in general, manufacturers are not required to provide safety data for the 100,000 chemicals in use since before 1981. It is up to the authorities to prove that a chemical is problematic, and conclusions are often challenged by the industry.

Even when problems have been recognised, it has been very difficult to use existing laws to control or ban the uses of hazardous chemicals. We know that some chemicals are capable of harming health and causing diseases yet they can still be used. Recent concerns have also focussed on long-lived chemicals that enter the environment during manufacturing, use and/or disposal of articles containing them. Many chemicals are now found in our bodies and the environment, even contaminating the oceans and polar regions and their wildlife.

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What is REACH?
Draft legislation on chemicals is currently being discussion by the European Union. The legislation will cover the Registration, Evaluation and Authorisation of Chemicals and is known as REACH. REACH aims to fill in the gaps in our knowledge of chemicals, put the burden on manufacturers to show that a chemical can be safely used and control or even ban the most hazardous chemicals.

In brief, manufacturers and importers of any chemicals produced or imported at over one tonne per year and on the market for more than two decades (an estimated 30,000 chemicals) will have to register such chemicals with a central agency and provide data on the characteristics and uses of the chemicals. This information will be evaluated, and the most hazardous chemicals of "very high concern" will be subjected to a system of authorisation ( see Questions 8, 9 and 10 ). Around 1500 chemicals may end up in this authorisation category.

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Why should I get involved in the debate about REACH?
REACH is one of the most important environmental laws that the EU is currently drafting. If strong enough, it will reduce the chemical contamination of our environment and of our bodies and improve the health of our children and their children. It will also help industry to take responsibility for the safety of the products from which they make profits. But REACH is in danger of being seriously weakened by industry. We need to ensure that the law puts health and environment first and we need to ensure that our governments and Members of the European Parliament hear our voices.

You can help the CHEMICAL REACTION campaign for effective legislation to make our future toxics-free - just click here >

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What needs improving in REACH?
Environmental groups would like to see the following in REACH:

• an obligation to phase out chemicals that accumulate in humans, wildlife or the environment, and those that interfere with our hormone systems or cause cancer. Restricted uses of such chemicals should only be permitted temporarily if safer alternatives are not available and there is an over-riding societal need for the specific use;
• a full right to know, so that consumers and businesses can judge the risks from chemicals, and including information about all dangerous chemicals present in products; and
• a requirement that products imported into the EU should conform to the same safety standards as those made in the EU.
• Provide sufficient safety data to identify dangerous chemicals and safer alternatives.

These points are not fully incorporated in the current draft of REACH. For example, a loophole in authorisation means that some of the worst chemicals could continue to be used indefinitely even if substitutes are available.

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When will REACH become law?
The European Commission published its proposed legislation in October 2003. This is now being discussed by the European Parliament and Council. But the massive lobbying power of the chemical industry has already delayed Parliament's work by a year. The final agreement is expected in the beginning of 2007. The law then becomes effective immediately, although chemicals will be phased into the REACH scheme.

A more detailed timetable can be seen here >

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Which chemicals should we be worried about?
The most hazardous chemicals are known as chemicals of "very high concern". These are chemicals that:

• do not break down quickly in the environment (very persistent chemicals) and can build up inside our bodies (very bio-accumulative chemicals); or have a combination of persistence, bio-accumulation and toxicity;
• are able to disturb our hormone systems (endocrine disrupters);
• can cause cancer (carcinogenic);
• can alter genes (mutagenic); or
• are toxic to the reproductive system;
• or are of "equivalent" concern.

There is increasing evidence that some synthetic chemicals are harming health. For example, chemicals are suspected of contributing to breast and testicular cancers, leukaemia, some allergies, reproductive problems and birth defects, early puberty in girls, and falling sperm counts. Chemicals also cause many cases of occupational diseases. For more information see: www.foe.co.uk/resource/factsheets/chemicals_and_your_health.html www.greenpeace.org.uk/Products/Toxics/humanbody.cfm

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Are there any examples of problem chemicals in everyday products?
Yes, many. For example:

Alkyltin compounds / organotin compounds: used as anti-bacterial agents and catalysts in the production of some plastics, eg, in some PVC and packaging. They are persistent, bio-accumulative and believed to interfere with hormone systems. Alkyltins can also attack the immune system and neurons in the brain.

Bisphenol A: used in the manufacture of linings for some food cans and lids, and is an ingredient in polycarbonate plastic bottles. It is a hormone disrupter and is suspected of affecting female and male reproductive organs.

Brominated flame retardants (BFRs) : used in fabrics in furniture and plastics (e.g. in personal computers) to counteract the spread of fires. Most BFRs are persistent and bio-accumulative, and several have been identified as hormone disrupters. Exposure has been shown to interfere with brain development in animals.

Phthalates: used in many PVC products (eg vinyl floor tiles, toys), glues and inks and as solvents in cosmetics and toiletries. A number of phthalates are hormone disrupters. Some cause liver, kidney and testicular damage.

Alkylphenols and derivatives: used as industrial detergents, and used in some paints and plastics. They are hormone disrupters and they can damage the immune system.

Artificial musks: fragrances added to many products like perfumes, cosmetics and laundry detergents. These are persistent and bio-accumulative and some are hormone disrupters. May cause liver damage and interfere with brain function.

Triclosan: an anti-bacterial chemical (sometimes marketed under the name "Microban ") which is added to a wide range of products, including washing-up liquids, liquid soaps, mouthwashes, dishcloths and chopping boards. It is now being detected as a contaminant in human breast milk and fish which demonstrates its poor breakdown in the environment and its ability to contaminate our bodies.

For more information, see www.foe.co.uk/resource/briefings/risky_chemicals_in_the_home.pdf
( PDF - 89K) [English]
www.greenpeace.org.uk/Products/Toxics/chemicalhouse.cfm [English]
www.chemical-cocktail.org/index_en.asp [English]
www.chemical-cocktail.org/index_fr.asp [French]

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How will registration work under REACH?
Manufacturers and importers will be required to document the safety of their substances. Therefore they will have to know about the chemical's properties, get information on uses from their clients, judge the risks the different chemical uses are posing to environment and human health and take/recommend safety measures. How much documentation is needed in the first instance will depend on the production volume of the chemical. Companies will be required to register all substances produced or imported in volumes of one tonne or more per year per manufacturer or importer (estimated to be around 30,000 substances).

The shortest deadlines for registration will apply to very high volume substances (above 1000 tonnes), and carcinogenic, mutagenic or reproductive toxics above one tonne. These will have to be registered within three years of REACH becoming law. Chemicals with production volumes in the range of 100 - 1,000 tonnes will have to be registered within six years; and low production volume chemicals (1 - 100 tonnes) will have 11 years for registration.

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What is evaluation?
The adequacy of or need for further information in the registration dossiers can be evaluated by the national authorities if the substance presents a risk to health or the environment. Any industry proposal for testing on animals will have to be checked and agreed by the authorities. Data (including existing data) from animal tests will have to be shared and this will avoid much new testing.

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Which chemicals will require authorisation?
Only substances of very high concern (see Question 6) will be subject to authorisation. An authorisation will grant permission for the substance to be used in specified uses only. As the draft stands, authorisation can be granted if the producer or importer can show that risks from the use in question can be "adequately controlled", or that the socio-economic benefits of the use of the substance outweigh the risks. In the latter case, the possibility of substitution with a less hazardous chemical should be considered.

Our view is that "adequate control" of very persistent and bio-accumulative chemicals is a flawed concept and that such chemicals should be phased out because of these intrinsic physical properties, without having to prove that they are harmful.

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Market and use restrictions
Next to the authorisation process, which will be completely controlled by a new international Agency, Member States can propose market and use restrictions for any chemical which they believe poses an unacceptable risk. This unfortunately continues the existing EU mechanism for controlling chemical risks and continues to put the burden of proof on the authorities. In the past this approach has not delivered sufficient protection and has only provided for regulatory action mostly after the damaged has happened. REACH might improve on this situation somewhat due to the collection of information at the registration process, but the restriction process overlaps with the authorisation procedure and does not provide for a clear paradigm shift to a precautionary approach in the way we deal with chemicals.

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What are the health and environmental benefits of REACH?
It is impossible to assign an exact value to the benefits of REACH. But they are expected to be highly significant and certainly outweigh the costs to industry. According to the European Commission, REACH might prevent over 4,000 deaths per year [1]. A modest 0.1% reduction in diseases related to chemicals would be worth € 50 billion over the next 30 years. In addition, there will also be considerable environmental benefits, including to wildlife.

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What will be the costs of REACH?
The European Commission has estimated that (as the draft stands) the registration and testing costs would be €2.3bn over 11 years (this includes fees to set up the new Chemicals Agency) [2]. This represents less than 0.05 per cent of chemical industry turnover, and only 2.7 per cent of current environmental spending and 2.4 per cent of the Research & Development programme of the industry. Alternatively, €2.3 billion corresponds to around 50 cents per EU citizen per year - or less than the cost of a chocolate bar [3].

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How will REACH affect business?
Despite alarmist claims by some sections of industry and the chemical lobby, over 40 impact studies (by whom?) have pointed to comparatively small costs for industry but great long-term benefits for businesses as well as consumers.

The former director general of the Confederation of British Industry and now vice chairman of Merrill Lynch, Adair Turner, has made the case for the use of regulation and taxes to promote environmental aims and has demolished the conventional arguments that they harm competitiveness and jobs [4].

The benefits to business of REACH include:

• harmonised standards for old and new chemicals.
• a more predictable regulatory system that will aid future long-term planning by industry.
• increased trust among consumers leading to new markets for safer and more environmentally friendly products allowing an easier introduction of new products and
• positive, forward-thinking development and innovation
• reduced the risk of future liability lawsuits, which can result in enormous costs (as has happened with asbestos).

Improved transparency and communication through the supply chain leading to increased power and confidence for downstream users and SMEs [5].

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How many animals will be used for testing the safety of chemicals?
REACH will require some animal testing in some cases. However REACH is taking many steps to reduce animal testing in the long term through:

• requiring the sharing of animal test data (including existing but previously private data);
• promoting development of non-animal tests and increasing the emphasis on the use of computer-modelling techniques;
• and by promoting a precautionary approach to the authorisation of chemicals of very high concern.

Environmental groups along with animal right groups strongly support mandatory data sharing to avoid unnecessary animal tests. In addition, we believe the very persistent and very bio-accumulative chemicals should be phased out without having to prove their toxicity.

It has been claimed that 13 million vertebrate animals could be used for tests. This claim is based on an outdated report [6] using the assumption that all 30,000 chemicals will need testing and that there is no available information from past testing programmes. The true figure will be far less.

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Are there chemicals that will not be included in REACH?
Pesticides, medicines, pharmaceuticals and cosmetics, and natural products will generally be outside the scope of REACH where they are covered by other legislation. However, there is no definitive list of chemicals that REACH will or will not cover.

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References
[1] European Commission, 2003, Extended Impact Assessment, 29 Oct 2003 , p. 11

[2] European Commission, 2003, Q and A on the new chemicals policy REACH

[3] International Chemical Secretariat, Feb 2004, Fact sheet, www.chemsec.org

[4] The Observer, 2003, When regulation is good, 27 July 2003
http://observer.guardian.co.uk/business/story/0,6903,1006462,00.html

[5] ' EEB and WWF discussion paper, January 2003, A new chemicals policy in Europe - new opportunities for industry.
www.eeb.org/activities/chemicals/Newchemicalspolicy-industry-29-01-03.pdf ( PDF)

[6] UK Institute for Environment and Health, 2001, Testing requirements for proposals under the EC White Paper 'Strategy for a future chemicals policy' . Institute for Environment and Health, Leicester, UK .
www.le.ac.uk/ieh/pdf/w6.pdf ( PDF)