FIA

REACH - Registration, Evaluation, Authorisation and restriction of Chemicals

1. What is REACH?

   REACH is a new European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of Chemicals.  It came into force in 1 June 2007 and replaces a number of European Directives and Regulations with a single system.  REACH has several aims:

   • To provide a high level of protection of human health and the environment from the use of chemicals.
   • To make the people who place chemicals on the market (manufacturers and importers) responsible for understanding and managing the risks associated with their use.
   • To allow the free mo vement of substances on the EU market.
   • To enhance innovation in, and the competitiveness of, the EU chemicals industry.
   • To promote the use of alternative methods for the assessment of hazardous properties of substances e.g. quantitative structure-activity relationships (QSAR) and read across.

2. What is the definition of an Importer in REACH?

   An Importer is defined as any natural or legal person established within the community who is responsible for directly importing anything from outside the EU/EEA, be it chemical substances (including metals), mixtures (e.g. paints, cosmetics), articles (finished products e.g. clothes or plastic goods) or articles that contain substances intended for release (e.g. a scented bin-liner).

3. What is the definition of a Manufacturer in REACH?

   A Manufacturer is defined as any natural or legal person established within the community who manufactures a substance within the community.

4. What is the definition of 'placing on the market'?

   In line with other EU directives and regulations, placing on the market is defined as:

   Supplying or making available, whether in return for payment or free of charge, to a third party. 

   Importing is deemed to be placing on the market.

5. What is a SIEF?

   A SIEF is the Substance Information Exchange Fora.  SIEF participants should include all relevant actors submitting information to the Agency on the same substance.

6. What chemicals are covered by REACH?

   Since 1 December2008, chemical substances manufactured in Europe in amounts of 1 tonne per year or more have needed to be registered with the European Chemicals Agency (ECHA) in Helsinki.

   It is only chemicals on their own that are registered, not deliberate mixtures of chemicals (formulations/preparations).  Where a chemical is supplied or used as part of a deliberate mixture, for example where it is produced and used in a solvent or as part of a product (e.g. paints or glues etc), it is the individual ingredients that are registered.  In some cases substances in articles need to be registered.

   There are a few exceptions, including radioactive substances, those in customs warehouses intended for re-export outside the EU/EEA, substances in transit and waste (as defined in EU Directives).  Inly selected parts of rEACH apply to some chemicals, e.g. human and veterinary medicines, food and food additives.  For others, e.g. intermediates, there are reduced requirements under certain circumstances, and some substances are treated as if they are already registered.  Mor information on the different exemptions can be found on the GSE REACH website:  http://www.hse.gov/uk/reach/index.htm

7. Who enforces the UK REACH Regulations

   The authorities given enforcement responsibility by the REACH Enforcement Regulations 2008 are those with eisting remits to protect human health consumer safety and the environment:

   • the Health and Safety Executive (HSE)
   • the Health and Safety Executive for Northern Ireland (HSENI)
   • the Environment Agency (EA)
   • the Scottish Environment Protection Agency (NIEA)
   • the Department of Energy and Climate Change (DECC)

   and

   • Local Authorities (LAs), as regards health and safety and consumer protection (Trading Standards)

   Regulation 3 and Schedule 1 of the REACH Enforcement Regulations 2008 sets out which enforcing authority is responsible for enforcing the listed REACH provisions, though broadly speaking:

   HSE, in its capacity as UK REACH CA, will enforce those duties in REACH concerning registration;

   HSE in Great Britain and HSENI in Northern Ireland will enforce supply chain related duties up to the point of retail sale, and for the retail sale local authority trading standards departments are responsible.

8. What are the penalities for non-compliance?

   The Enforcement Regulations allow for a breach of a listed REACH provision to be tried summarily (e.g. in Magistrates Courts) or on indictment (e.g. in Crown Courts), and provide that the same potential maxima permitted under the European Communities Act 1972.  These are currently:

   • up to £5,000 fine and/or up to three months imprisonment following summary conviction

   and

   • an unlimited fine and/or up to two years imprisonment following conviction on indictment.

   The Enforcement Regulations also provide for a number of supplementary criminal offences.  These include obstruction of inspector, prviding false statements, failing to comply wuth enforcement notices, and so on.  These supplementary offences are also the subject of criminal penalties wfich are consistent with those above.

9. How do I find out if my chemicals have been registered?

   The European Chemical Agency has a search facility on its website to allow users to search to find out if a chemical has been registered.  It also has downloadable lists of the chemicals registered:

   http://apps.echa.europa.eu/preregistered/prereistered-sub.aspx

10. What do I do if my chemicals are not registered?

    If the substance you use is not on the list, you should notify the European Chemicals Agency (ECHA), via the ECHA website, of your interest in this substance - giving your contact details and those of your current supplier.  The Agency will then 'advertise' on their website for a registrant for the particular substance.  If anyone comes forward to take on the responsibility they will be provided with your contact details as the downstream user (see FAQ 7) of the substance.

11. The deadline for pre-registration ended in December 2008, what do I do to register?

    As the 1 December 2008 deadline for general pre-registration has already passed, the only pre-registration function now available is for late pre-registration.

    For a substance to be eligible for late pre-registration the substance must be what is known as a 'phase-in' substance.  This means that:

    • The substance is listed on EINECS, i.e. those on the EU market before 1981
    • The substance was manufactured in the Community or in countreis acceding to the EU on 1 January 1995 or on 1 May 2004, but not placed on the market by the manufacturer, at least once in the 15 years before entry into force of this Regulation, provided the manufacturer has documentary evidence of this.  (Basically, these are substances that have been made in the EU but not placed on the market there.  They will generally be site limited or export only substances.  Evidence of this should be available if challenged).
    • The substance is a so called 'no longer polymer'.

    In addition, it must be the first time that the substance has been imported or manufactured in quantities of one tonne per year or more by the legal entitiy in question.  this needs to be done within 6 months of the first import/manufacture and no later than 12 months prior to the appropriate registration deadline.

    If it is not the first time the substance has been places on the market then the substance must be registered.

12. What is an article under REACH?

    An article is defined in REACH as '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'.

    Generally an article is usually a finished product.  Some examples of articles are clear cut, e.g. a telephone, a chair and a car (a car is an article made up of other articles - wheels, seats etc).  However, sometimes it is not easy to tell if something meets this definition, e.g. a metal bar can be an article if it has already been produced with a shape or size so that it can be engineered into another object (which will itself be an article).  However, it will not be an article if it hasn't been produced this way and is simply melted to make another metallic object.  It is the duty of the manufacturer/importer to decide if they are dealing with an article (where the shape, surface or design is most important) or a substance/preparation (where chemical composition is most important).

    Packaging is usually considered as an article under REACH.  If you receive goods to your premises from outside the EU or supply goods which are packaged, you need to consider the issues below for packaging.

    Note: you are not required to submit a registration to the ECHA for an article, rather it is the substance(s) in the article that may, in specific circumstances, be subject to (registration) requirements under REACH.

13. What is a Chemical Safety Assessment?

    This is carried out for all registered substances manufactured or imported at 10 tonnes per year or greater.  It should address all the identified uses of a substance on its own (including any major impurities and additives), in a preparation and in an article.    The assessment shall consider all stages of the life-cycle of the substance with the known or reasonably foreseeable exposure of man and/or the environment to that substance, taking into account implemented and recommended risk management measures and operational conditions.

14. When is a Chemical Safety Report (CSR) needed?

    A CSR should be completed for all substances subject to registration in quantities of 10 tonnes or more per year per registrant, and is a document of the chemical safty assessment.

15. What is a Competent Authority?

    The authority or authorities or b odies established by the Member States to carry out the oblications arising from the REACH Regulation.  In the UK the HSE is the Competent Authority.

16. Who is a Distributor under REACH?

    A Distributor is any natural or legal person established within the community, including a retailer, who only stores and places on the market a substance, on its own or in a preparation, for third parties.

17. What is the definition of a Downstream User?

    A Downstream User is any natural or legal person established within the community, other than the manufacturer or importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities.  A distributor or a consumer is not a downstream user.

18. What is an Exposure Scenario?

    Exposure Scenario's are the se of conditions, including operational conditions and risk management measures, that describe how a substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposure of humans and the environment.  These exposure scenarios may cover one specific process or use several processes or uses as appropriate.

19. What is the European Chemicals Agency (ECHA)?

    The ECHA is the agency established for the purposes of managing, and in some cases carrying out, the technical, scientific and administrative aspects of the REACH Regulation, and to ensure consistency at Community level in relation to these aspects.  The Agency is based in Helsinki, Finland.