European Union REACH
REACH is the EU regulation governing the manufacture and import of chemical substances. REACH is an acronym for the “registration, evaluation and authorization of chemicals” and has been in force in all EU Member States since June 1, 2007. It also applies in Iceland, Lichtenstein, and Norway.
REACH applies in principle to all chemical substances employed in the EU, including those used in industrial processes and also those used as part of consumers’ day-to-day lives. Examples include cleaning products, paints, and articles such as clothes, furniture, and electrical appliances.
REACH requires and encourages communication up to and down the supply chain, all the way to the consumer level, and it makes manufacturers responsible for their suppliers.
Failure to work up and down the supply chain can carry a risk—loss of business. An SVHC can be given a sunset date which, barring the granting of authorization, will lead to a ban of its use in the EU. It is also possible to have restrictions or authorizations for a specific use, sometimes on a temporary basis, as safer alternatives are sought.
In the long run, communication up to and down the supply chain in a timely manner ensures the most hazardous substances are substituted with less hazardous ones before any loss of business. If a manufacturer or distributor is unable to get the required information from their supplier, they may decide to stop purchasing from that supplier. This possibility can motivate many suppliers to be compliant before any EU member state REACH enforcement action can result in an even greater loss. The goal once hazards have been identified and prioritized is to test and substitute substances appropriately.
Private and international suppliers, distributors, importers, and others have often been required to field a massive number of information requests from the companies subject to REACH. Companies often do not have visibility into their own supply chains beyond their direct relationships so these requests entail a great deal of work, potentially requiring support to be compliant.
The European Commission's (EC) White Paper of 2001 on a ‘future chemical strategy’ proposed a system that requires chemicals manufactured in quantities of greater than 1 tonne to be ‘registered’, those manufactured in quantities greater than 100 tonnes to be ‘evaluated’, and certain substances of high concern (for example carcinogenic, mutagenic and toxic to reproduction - CMR's) to be ‘authorized’.
The EC adopted its proposal for a new scheme to manage the manufacture, importation, and supply of chemicals in Europe in October 2003. This proposal eventually became law once the European Parliament officially approved its final text of REACH. It came into force on 1 June 2007.
About 143,000 chemical substances marketed in the European Union were pre-registered by the 1 December 2008 deadline. Although pre-registering was not mandatory, it allows potential registrants much more time before they have to fully register. The supply of substances to the European market which has not been pre-registered or registered is illegal (known in REACH as "no data, no market").
REACH also addresses the continued use of chemical substances of very high concern (SVHC) because of their potential negative impacts on human health or the environment. From 1 June 2011, the European Chemicals Agency must be notified of the presence of SVHCs in articles if the total quantity used is more than one tonne per year and the SVHC is present at more than 0.1% of the mass of the object. Some uses of SVHCs may be subject to prior authorization from the European Chemicals Agency, and applicants for authorization will have to include plans to replace the use of the SVHC with a safer alternative (or, if no safer alternative exists, the applicant must work to find one) - known as substitution. As of 15 June 2015, there are 168 SVHCs on the candidate list for authorization.
REACH is the product of a wide-ranging overhaul of EU chemical policy. It passed the first reading in the European Parliament on 17 November 2005, and the Council of Ministers reached a political agreement for a common position on 13 December 2005. The European Parliament approved REACH on 13 December 2006 and the Council of Ministers formally adopted it on 18 December 2006. Weighing up expenditure versus profit has always been a significant issue, with the estimated cost of compliance being around €5 billion over 11 years, and the assumed health benefits of saved billions of euros in healthcare costs. However, there have been different studies on the estimated cost which vary considerably in the outcome. It came into force on 20 January 2009 and will be fully implemented by 2015.
A separate regulation – the CLP Regulation (for "Classification, Labelling, Packaging") – implements the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and will steadily replace the previous Dangerous Substances Directive and Dangerous Preparations Directive.
The REACH regulation was amended in April 2018 to include specific information requirements for nanomaterials.
Over a decade after REACH came into force, progress has been slow. Of the 100,000 chemicals used in Europe today, “only a small fraction has been thoroughly evaluated by authorities regarding their health and environmental properties and impacts, and even fewer are actually regulated,” according to a report for the European Commission.
Apart from the potential costs to industry and the complexity of the new law, REACH has also attracted concern because of animal testing. Animal tests on vertebrates are now required but allowed only once per each new substance and if suitable alternatives cannot be used. If a company pays for such tests, it must sell the rights of the results for a "reasonable" price, which is not defined. There are additional concerns that access to the necessary information may prove very costly for potential registrants needing to purchase it
How does REACH work?
REACH establishes procedures for collecting and assessing information on the properties and hazards of substances.
Companies need to register their substances and to do this they need to work together with other companies who are registering the same substance.
ECHA receives and evaluates individual registrations for their compliance, and the EU Member States evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA's scientific committees assess whether the risks of substances can be managed.
Authorities can ban hazardous substances if their risks are unmanageable. They can also decide to restrict a use or make it subject to prior authorization.
In general, REACH requires the registration of chemical substances manufactured or imported into the EU in quantities exceeding 1 metric ton per year. This requirement applies per substance and per manufacturer or importer (as appropriate). Registration applies to chemical substances as such, in preparations (also called “mixtures”) and, under certain conditions, to articles (finished products) incorporating those substances.
REACH assigns the obligation to register on the EU-based manufacturer or EU-based importer. Many U.S.-based companies prefer to appoint an “only representative” to register their product(s) rather than rely on their EU-based customers to do so. Only Representatives are commonly referred to by the acronym “OR”. Registrations are submitted to the European Chemicals Agency (ECHA)
Bearing in mind that the cost and burden of registering can be daunting, the EU exempted a limited number of substances from the registration requirement. These exemptions apply to:
You need to register if you are an:
There are two aspects to the REACH evaluation process: dossier evaluation and substance evaluation.
For dossier evaluation, ECHA is statutorily required to perform a compliance check on at least 5% of the dossiers submitted for registration. Dossier evaluation focuses on completeness and quality of information. ECHA will notify the registrant of any deficiencies.
For substance evaluation, each year ECHA and the EU Member States select 30 chemical substances for placement on the “Community Rolling Action Plan”, commonly referred to as “CoRAP”, for further evaluation. The Members States focus on those chemical substances that are manufactured/imported in large quantities and which are persistent and prone to bioaccumulation.
Each Member State has a designated agency that performs the evaluation; it is not performed by ECHA. Chemical substances placed on the CoRAP may eventually be subject to authorization or restriction.
U.S. companies that wish to export or use within the EU chemical substances identified as a “substance of very high concern” (SVHC) must ensure that a use authorization has been obtained. The policy objective of this requirement is to ensure adequate control and progressive replacement of these substances.
The restriction is another means under REACH that allows the European Commission to control the use of dangerous chemical substances circulated within the common market. Any chemical substance on its own, in preparation, or in an article may be subject to EU-wide use restrictions that limit or prohibit its production or use.
Role of the Companies in the Supply Chain Regarding REACH
REACH's effect on companies:
REACH impacts a wide range of companies across many sectors, even those who may not think of themselves as being involved with chemicals.
In general, under REACH you may have one of these roles:
Manufacturer: If you make chemicals, either to use yourself or to supply to other people (even if it is for export), then you will probably have some important responsibilities under REACH.
Importer: If you buy anything from outside the EU/EEA, you are likely to have some responsibilities under REACH. It may be individual chemicals, mixtures for onwards sales or finished products, like clothes, furniture, or plastic goods.
Downstream users: Most companies use chemicals, sometimes even without realizing it, therefore you need to check your obligations if you handle any chemicals in your industrial or professional activity. You might have some responsibilities under REACH.
Companies established outside the EU: If you are a company established outside the EU, you are not bound by the obligations of REACH, even if you export their products into the customs territory of the European Union. The responsibility for fulfilling the requirements of REACH, such as registration lies with the importers established in the European Union, or with the only representative of a non-EU manufacturer established in the European Union.
Benefits of our REACH Compliance Services
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Note 1: Intermediate registration and PPORD notification are much cheaper than REACH registration. If your substance meets the definitions of intermediate or PPORD, intermediate registration and PPORD notification are strongly recommended.
Note 2: If you place a chemical on the EU market, you shall also comply with CLP regulation.
Note 3: companies shall start acting now and prepare for the coming reach registration deadlines in 2013.
Kindly please contact us in case you need to get the EU REACH approval.
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