The EU Council of Ministers, the highest legislative body in the bloc, voted in favour of theRegistration, Evaluation and Authorisation of Chemicals (Reach), on 18 December, with thelegislation due to come into effect on 1 June 2007.
Reach transfers the burden of proof regarding testing and evaluation of the risks of chemicals toindustry from regulators. Businesses will now need to prove the safety of thousands of chemicalspreviously not regulated by the bloc. REACH would also require producers and users to replace someof the current chemicals in use with safer alternatives, if they exist.
For end users, the main cost will be from the requirement that they keep records of all thechemicals they use, and for what purpose.
While the food industry lobbied hard to gain exemptions for certain chemical ingredients theyuse, some of the products they use will still be covered by Reach, said Marta Bertran, manager of scientificand regulatory affairs for the Confederation of the Food and Drink Industries of the EU.
"Some of the products used in the food and drink industries will still be covered by Reach,such as packaging materials and cleaning products," she told FoodProductionDaily.com. "So at the moment we are analysing the main implications as'downstream users' of these products in order to inform our members.
She noted that the manufacturers of such products, for example packaging manufacturers, wouldhave to register them under Reach. Processors would then have to make sure that their use for a foodand drink application have been notified by the producer.
Over the three years of debate on Reach, the CIAA has successfully lobbied parliamentarians toexplicitly exclude food and feed from the regulation. The CIAA and other industry associationsargued that food and feed were already covered by the traceability requirements as defined by the General Food Law Regulation 178/2002.
However the concession for some ingredients could result in confusion for end users, the CIAAargued. Regulation 178/2002 requires companies to trace food, feed, and ingredients through all stages of production, processing and distribution.
"A number of product categories, including some food ingredients, have been excluded from the scope of theReach proposal since they are covered by other EU legislation, in order to avoid double legislation,"the association said in a memorandum at the start of this year. "The fact that some food materials arein, and some are out of the scope, causes confusion and inconsistency at many levels."
Meanwhile a spokesperson for the UK's Food and Drink Federation (FDF) said the association is nowlooking at the industry's responsibilities as downstream users.
The FDF has developed guidance for members to assist their understanding of Reach's requirements, including practical guidance to assist them in discussions with their chemical suppliers to ensure continuity of business in terms of their need for chemicals such as cleaning agents, lubricants, inksand other products.
The FDF also supports the views of the Confederation of British Industry (CBI) on the overall assessment of the impact of the regulation on theindustry, the spokesperson said.
"The impact of the regulation on firms will be substantial, and will revolutionise the way in which a huge variety of substances are managed bycompanies," she said. "It also extends far beyond the traditional chemicals sector to many businesses, including small firms, that haven't traditionally thought of themselves as handling chemical substances."
While Reach comes into effect on 1 June, its provisions will be slowly phased in over the next 11years.
Reach replaces 40 legislative texts with a single single system regulated by a single EUChemicals Agency, to be based in Helsinki, which will be responsible for the registration andauthorisation process.
For the first time about 100,000 substances placed on the market before 1981 will have to beapproved and registered with a newly created regulator. These are chemicals that did not have toundergo health and safety tests, which became mandatory in the EU for the 3,000 substancesintroduced for use from 1981.
The authorisation process will initially cover about 2,500 substances considered more risky thanthe rest. The agency will be responsible for authorising them and the producers will have topresent either replacement proposals or research plans to develop alternatives. The authorisationwill be for a limited time period.
For more hazardous substances, producers will have to submit a substitution plan to replace themwith safer alternatives. When no alternative exists, producers will have to present a research planaimed at finding one.
In the main the unified law would affect processors by applying to the chemicals used for makingpackaging. However it could also apply to cleaning chemicals and other substances used in plants.Workers unions have said the regulation is an important step forward in making manufacturing plantsa more healthier environment for their members.
Business industry associations said the law would in some cases leave downstream users scramblingto find alternative suppliers for the chemicals used in their manufacturing operations.
"This will generate an additional burden for chemical producers and downstream usersalike," the Confederation of European Business (UNICE), the European Association of Metals,The European Engineering Industries Association (Orgalime) and the European Chemical IndustryCouncil said in a joint statement. "It will equally affect the supply of raw materials fordifferent sectors of EU industry, and this without any clear benefit for the end consumer."
This is because producers would be required to submit a plan for all substances that can besubstituted with a suitable alternative, even if they are adequately controlled, said Orgalimesecretary general, Adrian Harris.
"Substitution not only requires time, but does not automatically represent the bestoption in terms of safety, functionality or overall environment performance of a product,"he said. "Besides, we yet have to be convinced that the provisions on substances in articleswill be enforceable and workable in practice. Also, information communication obligations forarticle manufacturers have been extended. This risks multiplying existing communication obligationswhilst causing confusion among consumers."
Reach also includes obligations of duty of care for the industry and of communication to thepublic about dangerous substances in products. It also includes safeguards for confidentialinformation and provisions to avoid duplication of animal testing.
The European Trade Union Confederation (ETUC) said it welcomes the REACH regulation's passage,but criticised the success of the chemical industry in restricting its scope.
"The law as adopted puts the burden of proof firmly on producers for the 30,000substances covered by the reform," the association stated. "But the ETUC can onlycondemn the chemical industry's 7-year lobbying campaign to get the European institutions to scaledown the reform. More specifically, European trade unions take issue with the fact that informationvital to protecting workers' health given in the chemical safety reports will now only be requiredfor a third of the chemicals originally planned."
Some 17,000 chemicals of low priority will now be excluded from onerous testingrequirements, as originally proposed.