New REACH Regulations Have Far Reaching Implications for Bike Sector
Yesterday, the European regulations on the Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH) entered its next phase. On June 1, 2007 this law entered into force and is being implemented step by step. REACH is all about:
BRUSSELS, Belgium – Yesterday, the European regulations on the ‘Registration, Evaluation, Authorisation and Restriction of Chemical substances’ (REACH) entered its next phase. Already on June 1, 2007 this law entered into force and is being implemented step by step. REACH is all about:
“The protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances as substance and in products marketed in Europe.” Although REACH seems at first to be an issue for the chemical industry, it has major implications for all businesses including the bike sector in Europe.
Why would the bicycle sector have to bother about EU regulations regarding chemicals? All products marketed by the bike and P&A makers, importers and distributors (later referred to as downstream users) in Europe do contain one or more chemicals or mixtures of chemicals (further referred to as ‘preparations’). The REACH Regulation gives greater responsibility to industries to manage the risks from chemicals and to provide safety information on the substances.
Manufacturers and chemical importers will be required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database run by the European Chemicals Agency (ECHA) in Helsinki. The Agency will act as the central point in the REACH system. It will manage the databases necessary to operate the system, co-ordinate the in-depth evaluation of suspicious chemicals, and run a public database in which consumers and professionals can find hazard information.
One of the main reasons for developing and adopting the REACH Regulation was that a large number of substances have been manufactured and placed on the market in Europe for many years, sometimes in very high amounts, and yet there is insufficient information on the hazards they pose to human health and the environment. There is a need to fill these information gaps, to ensure that industries are able to assess hazards and risks of the substances, and to identify and implement the risk management measures to protect humans and the environment.
By 30 November 2010 chemical producing and importing companies need to document the risk management of chemicals by sending a registration dossier to the European Chemicals Agency, ECHA. This is necessary for the continuation of production and marketing of substances manufactured or imported above 1000 tonnes per year, of some substances with specific hazardous properties above 1 tonne per year, and for substances very toxic to the aquatic environment above 100 tonnes per year.
To prepare their dossier, the chemical companies and importers will need to share data with others in a Substance Information Exchange Forum (SIEF). SIEFs bring together businesses registering the same substance so they can share data on it. This reduces costs, avoids duplication of animal testing, and allows the SMEs (Small to Medium Enterprises) to benefit from data gathered by bigger companies, which should be exchanged for a fair price.
The Downstream Users
Under REACH, downstream users must not market or use any substances which are not registered in accordance with REACH. Downstream users will receive information on dangerous substances and preparations, including risks from their use and measures to control these risks, in safety data sheets, just like before. Some safety data sheets will have an annex, called an exposure scenario. This exposure scenario will give more specific information on how to use the substance or preparation safely and how you can protect yourself, your customers and the environment from risks.
If your use is not covered, communicate with your supplier with the aim of having your use covered by an exposure scenario or you may need to develop your own chemical safety report. You must comply with the risk management measures and with any restrictions on the use of the substance. Downstream users must also communicate certain information upstream and downstream in the supply chain.
Regardless of the type of commercial activity carried, all downstream users should check when they purchase chemical substances or preparations (including e.g. cleaning agents, solvents and similar products) from outside the EU. If companies are responsible for the physical introduction of substances or preparations into the EU, they have the role of an importer under REACH and you may have to register the substances. Importers of articles might also have to fulfil requirements under REACH. If they purchase from a supplier in another EU country, they are not an importer and do not have to register.
REACH for distributors and retailers
A distributor under REACH is an actor who only stores and sells substances and preparations exclusively inside the EU, without any kind of modifications or repackaging. A retailer under REACH is an actor who sells substances and preparations to private consumers and/or professional users in retail stores. Retailers are a sub-group of distributors. Storage providers, who only store substances or preparations, are also a sub-group of distributors. As long as they don’t perform any operations or activities with them, they only have to forward information in the supply chain.
The distributors have the obligation to pass on information on the goods they distribute from one actor in the supply chain to another. This includes safety data sheets for substances and preparations. Furthermore, it requires certain information to be provided for substances, preparations or articles when a safety data sheet is not required. Distributors are not downstream users of substances or preparations according to REACH, but have a key position regarding information flow within the supply chain.
The distributors can prepare themselves on REACH by, for example, initiating communication between a manufacture or an importer of substances and their customers, who will often be downstream users. The downstream users could be those handling semi-final products as well as the end users of substances and preparations.
Last October the Forum for Exchange of Information on Enforcement of REACH approved a new enforcement project focused on Downstream Users. This enforcement project “REACH-EN-FORCE 2” aims to ensure compliance with duties placed on formulators of mixtures as they have important responsibilities further down the supply chain for many essential requirements imposed by the REACH and CLP Regulations.
Specifically, the inspectors will control the supply chain related obligations for substances in the mixtures prepared by formulators as well as the CLP notification requirements. They will also check if the substances placed on the market in mixtures are registered or pre-registered. In addition, the inspectors will raise awareness of the future obligations for downstream users with relation to the extended safety data sheet.
What is the European Chemicals Agency?
The European Chemicals Agency (ECHA) manages and carries out technical, scientific and administrative aspects of REACH: it receives the pre-registrations and registrations and will co-ordinate the evaluation, authorisation and restriction processes. It ensures consistency at the Community level in relation to these aspects and provides the Member States and the institutions of the Community with the best possible scientific and technical advice on questions relating to chemicals which fall under REACH.
The Agency’s website is providing industries with guidance and tools and gives the public a range of information on registered chemicals. In a way, chemical manufacturers and importers can be seen as ECHA’s major clients. They will have to pay for the different REACH procedures and in return they have the right to expect to get their dossiers processed efficiently and correctly.
What is a Downstream User?
A downstream user is someone who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities. Many different types of companies can be downstream users, including formulators of preparations, producers of articles, craftsmen, workshops and service providers or re-fillers. This guidance is also aimed at other actors in the supply chain, who are not downstream users or manufacturers and importers, but still have obligations under REACH. This includes distributors, retailers and storage providers.
It is to be noted that almost all industry sectors have to apply the REACH downstream user provisions, so in fact ECHA interacts with companies far beyond the chemical industry, continuing dialogue with the industries in the context of the finalisation and updating of guidance documents.
In the end: What about the Consumers?
The benefits of REACH to consumers will rise from improved information on chemicals during their entire life cycle and the more detailed assessments carried out by companies on dangerous chemicals, leading to better safety instructions for users and, ultimately, for consumers. Some uses will also be restricted or banned for safety reasons.
The consumers will also have access to more information on the properties of chemicals, e.g. the public information on the Agency website. Consumers will be better informed, less exposed to and better protected from dangerous chemicals. In addition, REACH introduces a duty to communicate information on substances in articles, especially with regard to very toxic chemicals. The use of that category of chemicals will also be subject to the authorisation procedure leading ultimately to much more limited risks for consumers or complete substitution of the chemical.
New Regulation on Labelling and Packaging
CLP Regulation is the new European Regulation on Classification, Labelling and Packaging of chemical substances and mixtures. The legislation introduces throughout the EU a new system for classifying and labelling chemicals, based on the United Nations’ Globally Harmonised System. CLP is about the hazards of chemical substances and mixtures and how to inform others about them.
It is the task of industry to establish what are the hazards of substances and mixtures before these are placed on the market, and to classify them in line with the identified hazards. In case a substance or a mixture is hazardous, it has to be labelled so that workers and consumers know about its effects before they handle it.
Dig deeper into REACH. A list of links can be found on www.bike-eu.com/facts-figures/eu-regulations/