A: Details of the scope of REACH and what is considered exempt can be found on the 'About REACH' page under 'scope and exemptions'.
A: A substance is defined under REACH as 'a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition'.
If you import (from outside the European Union) or manufacture a substance at or over 1 tonne per year then it is likely you will need to register this substance. This also applies to substances in preparations. For this, we suggest that companies check with their suppliers the exact composition of the substance in order to be able to calculate if they are importing over a tonne of a substance. Please note that tonnage thresholds are per importer not per preparation i.e. you may import several preparations all containing the same substance.
The REACH Regulation applies in certain cases to articles. There is a specific REACH definition for articles that you should consider before deciding whether you produce or import articles. However, generally speaking an article is a finished product such as clothing, furniture, motor vehicle parts etc.
Substances contained in articles are to be registered if they are intended to be released and they are in those articles in quantities totalling over 1 tonne per year. For most articles it is unlikely a registration will be required as very few intentionally release substances.
In addition, if the articles contain Substances of Very High Concern (SVHCs) which are listed on the candidate list for authorisation, the producer or importer of the article has an obligation to notify these substances to the European Chemicals Agency (EChA), if the substance is present in those articles in quantities over 1 tonne per producer/importer per year and the concentration is above 0.1 % (w/w) in the article as produced or imported. On request, any supplier of an article also has the duty to communicate information on SVHCs in articles to users and consumers, to allow for safe use of the article.
A: There are four key contributors to REACH:
A: Substances that fall into scope will need to be registered according to a timetable laid out in the regulation. If it is not registered then it becomes illegal to supply or import it into the EU. Following registration the information submitted ("dossiers") on substances will be evaluated for compliance with the requirements of the Regulation and to check any proposals for testing. The European Chemicals Agency will, with Member States, develop a rolling programme of substances prioritised for further evaluation where there are suspicions of risk to human health and/or the environment for consideration of regulatory action. Substances with properties of very high concern (e.g. carcinogens, mutagens, damaging to reproduction, dangerous to the environment) will be made subject to authorisation. In some cases the manufacture, placing on the market or use of certain dangerous substances shall be subject to EU-wide restrictions. An important element is that better information on hazards and risks and how to manage them will be passed down.
A: The timescales for registration under REACH can be found on the 'when do I have to comply?' page.
A: In order to pre-register your substance you should submit to the ECHA (see Article 28 of REACH text for details):
This information shall be submitted between the 1st June 2008 and 30th November 2008. This is no charge for the submission of pre-registration information.
A: For substances to be registered under REACH a technical dossier is required for substances in quantities of 1 tonne per year or more and a chemical safety report (CSR) for substances in quantities of 10 tonnes per year or more. This should be submitted to the ECHA by the relevant deadline at the latest.
A: Yes, it will cost to register a substance under REACH. The amount has not yet been decided. It will not cost to pre-register your substance.
A: The technical dossier contains information on the properties, uses and on the classification of a substance as well as guidance on safe use; this is required for substances in quantities of 1 tonne per year or more.
A: The requirements of the CSA are described in Annex I of the REACH text, this is basically the information needed in order to produce the Chemical Safety Report (CSR) for substances supplied in quantities of 10 tonnes per year or more. This includes the following steps:
A: The chemical safety report documents the hazards and classification of a substance and the assessment as to whether the substance is persistent (P), bioaccumulative (B) and toxic (T) or vPvB (very Persistent very Bioaccumulative). The chemical safety report also describes "exposure scenarios".
A: These are sets of conditions that describe how substances are manufactured or used during their life-cycle and how the manufacturer or importer controls, or recommends to control, exposures to humans and the environment. They must also include the appropriate risk management measures and operational conditions that, when properly implemented, ensure that the risk from substances are adequately controlled. They should cover all the manufacturers’ or importers’ own uses and uses made known to the manufacturer or importer by their downstream users.
A: Use and placing on the market of substances of very high concern will require an authorisation. Article 57 identifies the criteria for very high concern substances which are:
Substances that fall into these categories will be fed into the authorisation system as resources allow.
A: REACH is designed to ensure that all actors in the supply chain, be they manufacturers or downstream users, have the information they need to use the chemicals safely. This requires communication of information related to health, safety and environmental properties, risk and risk management measures both up and down the supply chain. Commercially sensitive information i.e. tonnage data is not required to be exchanged.
The primary tool for this is the safety data sheet (SDS) which applies to dangerous substances. The existing provisions of the safety data sheets directive (91/155/EEC) are carried over into the REACH legislation with additional requirements on the provision of SDS when substances (or preparation containing them) are PBT or vPvB. Where chemical safety assessments (CSAs) are performed according to registration requirements, relevant exposure scenarios shall be annexed to the SDS and passed up or down the supply chain accordingly.
Any new information which comes to light on the hazardous properties of a substance, or information which may lead to alterations of risk management measures outlined in the Safety Data Sheet (SDS) shall be passed up the supply chain.A: NONS continues to exist until 1st June 2008, when notifiers responsibilities under these regulations are repealed.
Substances that have been notified under NONS and have a recognised notification number will be transferred into REACH and will be regarded as already having been registered. When they get to the next REACH tonnage threshold the notifier/registrant will need to comply with the relevant requirements for that level under REACH [Article 24].
A: Any PORD (Process Orientated Research and Development) exemption granted under the NONS scheme will be no longer valid from the 1st June 2008, as 67/548/EEC is repealed on this date. Research activity can continue under REACH, but you would need to apply for a PPORD under REACH if this research activity is taking place at a level of 1 tonne or more per annum.
Also, in order to avoid interruption of such activities between the repeal of 67/548/EEC and implementation of REACH, the application should be made by the 16th May 2008 at the latest. This is because under current indications, PPORD activities may not start earlier than two weeks after notification. Therefore, the agency will allow notification before the 1st June 2008 even though the PPORD activities can only commence on the 1st June 2008 as that is when PORDs under NONS are dissolved and this aspect of REACH comes in to force. Details of PPORDs can be found at the ECHA website.
A: This is explained in Article 15 of the REACH text.
Any active substance on Annex I or IA of the Biocidal Products Directive, or any active substance that is in the review programme are regarded as being registered under REACH.
Similarly, any active substance or co-formulant that appears on Annex I of the Plant Protection Products Directive or is in the review programme is regarded as being registered under REACH.
Please note that any non-biocidal/non-plant protection uses of the chemical will have to be registered under REACH if the substance is manufactured or imported at 1 tonne or more per year.
Any non-active components in Biocidal or Plant Protection Products will have to be registered if they are manufactured or imported into the EU in quantities of 1 tonne or more per year.
Biocidal active substances are not totally exempted from REACH and certain provisions of this legislation will apply to suppliers of biocidal active substances/products, principally to supply information up and down the supply chain. There is also a requirement to participate in any SIEFs for active substances registered for other purposes or for non-actives generally.
A: Alloys are to be treated as "special preparations" under REACH and it will be the constituent elements that will require registration, e.g the iron, nickel, chromium etc. which make up the alloy.
A: Some plant/botanical extracts can be considered as exempt from certain aspects of REACH under Article 2, this is if they fall under the definition of ‘substances which occur in nature’. This is defined within Article 3, paragraph 39 of the REACH text as ‘a naturally occurring substance as such, unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which is extracted from air by any means’.
If this definition applies, then such substances are exempted under Annex V of the REACH text.
A: As highlighted above your SDS is a key tool in the communication of information up and down the supply chain. Ensure you keep this up to date and look at Annex II of the REACH text to check that you have the correct information available within this sheet. In the likelihood of exposure scenarios being produced to fulfill CSA requirements make sure these are attached to your SDS if relevant to your particular use.
A: The EU is still considering whether or not nanosubstances require special treatment under REACH [but in principle if the substance is supplied or imported at greater than 1 tonne per annum then yes it would be in the scope of REACH].
A: REACH will apply in addition to COSHH and will sit alongside it. Mostly, REACH will result in improved information being sent down the supply chain about the hazards and risks posed by chemicals. There should duly be a general improvement in the quality of safety data sheets and in advice on control measures to help end users of chemicals with their COSHH assessments. In some cases, existing assessments should be refined; in others they may not need further amendment i.e. COSHH assessments for most relatively non hazardous substances may not need to be changed.
A: Mostly they don’t but on occasion a registration may be required.
Substances, on their own, in preparations or in articles which have been registered and which are recovered in the EU, are not required to be registered if the substance that results from the recovery process is the same as the substance that has been registered. However, it is possible that in some cases the recovered material will NOT be the same as the registered material. In those cases the substance will be required to be registered. The reason is that the recycler would now be considered to be the producer/manufacturer of a substance and would therefore have an obligation to register that substance.