The EU's Registration Evaluation and Authorisation of Chemicals (Reach) puts the onus on businesses to demonstrate that the chemicals they use are safe. Most chemicals being used in the bloc will have to be registered with the new EU regulator. While the food industry lobbied hard to gain exemptions for certain ingredients, some of the products they use will still be covered by Reach, including packaging and cleaning chemicals. Reach would also require producers and users to replace some of 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 the chemicals they use, and for what purpose. Under Reach, manufacturers, importers, distributors and users must ensure that these are registered with the European Chemicals Agency in Helsinki. The need to register comes into force on 1 June 2008. If a producer pre-registers before 1 December 2008, then it is granted the right to spread the full registration over the 11 years to 2019, depending on the tonnage produced. Reach transfers the burden of proof regarding testing and evaluation of the risks of chemicals to industry from regulators. Businesses will now need to prove the safety of thousands of chemicals previously not regulated by the bloc. The agency will require companies to provide information about the characteristics and hazards, if any, associated with a chemical. The regulator has the option of banning chemicals that pose a serious hazard or restricting their use through the grant of a specific "authorisation". Although in general the registration obligations fall on manufacturers and importers, downstream users such as food processors will need to ensure that their specific uses are registered. Processors will also have to tell their suppliers how they use the substances in their products. Reach directly imposes its obligations on companies from 1 June 2007 without member states having to implement national laws. Europen, the EU's packaging association, this week reminded its members that the legislation also deals with substances in articles and in preparations. Packaging falls under a definition in the regulation that states that an "article" covered by law "means an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition." Pulp and paper, plastics, metals, glass, coatings, printing inks and adhesives are among materials used in packaging that are affected by Reach, the association stated. "Packaging material suppliers, converters and importers of raw materials and finished goods should ensure that they are aware of their obligations under the provisions dealing with substances in articles, of the need for preregistration and registration of substances and, in some cases, authorisation of the substances," Europen stated in the current issue of its newsletter. In general, substances on their own, in preparations such as inks, coatings and adhesives, or in packaging may only be manufactured, put on the market and used in the applications for which they are registered. "The deadlines for taking actions are very tight and the most urgent step to conside is pre-registration," the association stated. "Companies should begin to audit their product portfolios now and initiate dialogue with customers and suppliers." The association also urged its members to contact packaging converters and brand owners such as processors to push their suppliers to pre-register all substances during the mandatory June to December 2008 phase in period. "While there is no penalty for not subsequently registering substances that have been pre-registered, there is no guarantee that substances that have not been pre-registered can be registered according to the timeline laid down in the regulation," the association warned. Unregistered substances will eventually have to be taken off the market. Under Reach companies can postpone making a decision on which substances may or may not have to be withdrawn from the market on condition that they have been pre-registered. Reach was passed by the EU to ensure that the 10,000 chemicals on the market will get tested for their effects on health and on the environment. It is also meant to encourage the replacement of hazardous chemicals with safer ones and to spur the chemicals sector into researching and developing more new products.
