ISL Praxis : Reach Services

REACH (Registration, Evaluation and Authorisation of Chemicals) is new European Union legislation on the handling of chemicals and other substances (including metals). It was agreed by the European Parliament on 18th December 2006 and enters into force on 1st June 2007.

The REACH Regulations are aimed at ensuring a high level of protection for human health and the environment from hazardous chemicals. This rationalises the existing EU regulatory system for chemicals and in doing so replace over 40 pieces of current legislation. The REACH Regulations aim to address a number of serious short-comings in the current legislation which include:

• a lack of available information on risks to human health and the environment for the majority of chemical substances on the EU market;
• the slow and resource-intensive nature of the current system;
• transferring the responsibility for the assessment of chemicals from the regulatory authorities to industry; and
• distortions of the internal market inherent in the current fragmented legislative regime.

REACH introduces a new registration requirement covering all substances supplied above 1 tonne per year, and a new authorisation requirement covering substances of very high concern (e.g. carcinogens).

A key part of the REACH Regulations is the establishment of an EU Chemicals Agency which is to be based in Helsinki and will have responsibility for managing REACH. This Agency will receive and evaluate registrations and may also instigate authorisations and restrictions on the manufacture and importation of chemicals considered to be particularly hazardous to human health or the environment. The EU Chemicals Agency will administer REACH in co-operation with the Competent Authorities of member states.

DEFRA (Department for Environment, Food and Rural Affairs) is the lead government department responsible for implementing REACH in the UK. The Competent Authority for REACH in the UK is the HSE (Health and Safety Executive). In this role the HSE are responsible for:

• providing a Helpdesk for (national) duty holders and other stakeholders
• monitoring compliance
• evaluating substances of concern (e.g. Classification & Labelling, restrictions on use)
• taking regulatory action as appropriate
• coordinating UK enforcement of the regulations (e.g. the implementation by users of the risk management measures designated by suppliers; the adherence to restrictions or Authorisation)

In their role as competent authority the HSE will work closely with DEFRA, the Environment Agency, the devolved administrations and other government departments including the DTI.

The HSE helpdesk can be contacted on 0845 408 9575 or via email at: ukreachca@hse.gsi.gov.uk

How we can help
The implications of REACH are entirely dependent on your business activity, as detailed on this web-site. It may involve a substantial amount of preparative work and has the potential to seriously impact your business activities. Imagine the impact to your business if a key raw material that you have used for decades suddenly became unavailable and you had not identified appropriate alternatives with the necessary supply chain.

ISL Praxis can help you no matter what your business activity. We offer the following services which will give you the confidence that your responsibilities under REACH are being appropriately managed and enable you to focus on your core business activities.

ISL Praxis REACH Toolbox

• Initial REACH Impact assessment: Are you in, or out?
• REACH Vulnerability Assessment: assessing vulnerability; level of existing preparedness; portfolio analysis; assessment of supply chain risks.
• Produce an inventory of substances and preparations, establishing annual usage
• Assess reliability of suppliers and potential benefits of alternative suppliers
• Preparation of Technical Dossiers
• Preparation of Chemical Safety Reports
• Preparation of Chemical Safety Assessments
• Act as your representative on consortia etc.
• Train your staff on the implications and methodologies for REACH compliance
• Provide technical assistance in regulatory negotiations
  
  … and more; please ask for details of services that can meet your business needs in this area.

Who does it affect?
REACH is the most significant change of chemicals legislation to take place for more than 40 years. It has major implications for everyone involved in the use of chemicals and other substances (including metals), from producers within the chemical industry to downstream users through to end users of these substances. Specifically the REACH Regulations apply to:

• chemical manufacturers within the European Union
• chemical importers into the European Union
• downstream users (e.g. electronics, rubber & plastics, adhesives, paints, coatings, inks, food & drink etc.)

end use industrial sectors (e.g. surface coating, automotive, aerospace, engineering, paper & packaging, personal care etc.)

There are over 30,000 substances on the EU market used in quantities above 1 tonne per year. This gives some idea of the scale of organisations that will be affected by REACH. To give some perspective of the work that will be involved, the current regulatory system has properly assessed less than 200 substances over the past 30 years.

Downstream Users
The emphasis of REACH is on manufacturers and importers of chemicals. However, downstream users have the following rights and obligations:

• they have the right to join a Substance Information Exchange Forum during the registration process
• they have the right to request that their supplier’s chemical safety assessment covers their uses(s)
• they are obliged to implement risk reduction measures recommended by their suppliers
• under certain circumstances they may be obliged to carry out a risk assessment covering their particular use(s) of a chemical

Small to Medium Enterprises (SMEs)
There are 20,000 to 30,000 substances subject to REACH registration that are supplied in the range 1-10 tonnes per year mainly by SMEs. For SMEs the following circumstances exist:

• special provisions to help SME low tonnage suppliers
• greatly reduced information requirements for substances supplied in the range 1-10 tonnes
• 1-10 tonnes substances have 11 years to register (by June 2018)
• there are reduced fees for SMEs in all areas of REACH

The new EU Chemicals Agency will take particular account of SME needs in preparing technical guidance and enforcement strategies.

If you use chemicals and other substances such as metals, then the REACH Regulations will have an impact on your operations.

How does it work?
The REACH Regulations have 3 main elements which are summarised below:
registration – a manufacturer or importer will need to register any substances they supply to the EU market above the 1 tonne per year level

• evaluation – the authorities will carry out annual in-depth evaluations (i.e. assessments) of substances flagged as being of potential risk (e.g. on the basis of information provided at registration)
• authorisation/Restriction – the use of substances of very high concern will require authorisation. Examples of ‘very high concern’ substance include:
  • CMRs (Carcinogens, Mutagens and toxic to Reproductive)
  • PBTs (Persistant, Bioaccumulative and Toxic)
  • vPvBs (very Persistent, very Bioaccumulative)

Registration
Depending on the hazardous nature of the material and the annual tonnage the phase-in period for substances will be 3, 6 or 11 years with the most hazardous materials registered in the first tranche. These timings are summarised in the diagram and in more detail in the table below.

The process of registration involves the submission to the EU Chemicals Agency of a technical dossier for substances in quantities of 1 tonne or more, and a chemical safety report for substances in quantities of 10 tonnes or more.

Technical Dossier
This contains data on the physicochemical properties of the substance together with information on its environmental and health impact. To find out the properties of the substances, information requirements are set out in the testing annexes of the Regulations that vary according to the tonnage in which the substance is manufactured or imported, and to the needs of the chemical safety assessment. The tonnage trigger has been chosen as it gives an indication of the potential for exposure.

General rules are also set for the use of existing information, techniques such as (Q)SARs (Quantitative Structure Activity Relationship) and read across, and for waiving of tests (omitting them if they are not required because of their use or it is not technically possible to carry them out). New tests are only required when it is not possible to provide the information in any other permitted way. Where new tests are carried out there are general provisions on the generation of information to ensure the quality of the information. Application of Good Laboratory Practice (GLP) is required only for toxicological and eco-toxicological test and analyses.

Technical Dossier Contents Required for Registration under REACH

1. Identity of manufacturer or importer
2. Identity of the substance
3. Information on the tonnage manufactured/imported
4. Brief description of manufacturing technology for manufacturing organisations
5. Indication of volume split between own and downstream use(s)
6. Physical form in which made available for downstream use
7. Brief description of identified uses
8. Uses advised against
9. The classification and labelling of the substance
10. Guidance on safe use of the substance
11. Information and study summaries associated with Annexes VII – X as applicable
12. An indication as to which of the above data has been reviewed by an experience assessor
13. Exposure information for substances above 1-10 tonnes, as given in Annex VI of the Regulation

Chemical Safety Report
The Chemical Safety Report for substances manufactured or imported in quantities starting at 10 tonnes, documents the hazards and classification of a substance and the assessment as to whether the substance is PBT or VPvB. It also describes exposure scenarios for specific uses of substances that are classified as dangerous or are PBT or VPvB substances. Exposure scenarios 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 of humans and the environment. The exposure scenarios must include the appropriate risk management measures and operational conditions that, when properly implemented, ensure that the risks from the uses of the substances are adequately controlled. Exposure scenarios need to be developed to cover all ‘identified uses’ which are the manufacturers’ or importers’ own uses, and uses which are made known to the manufacturer or importer by his downstream users. Relevant exposure scenarios need to be annexed to the safety data sheets that will be supplied to downstream users and distributors.

To reduce costs for industry, registrants are required to jointly submit information on the hazardous properties of the substances and it classification. They can also, if they agree, jointly submit the chemical safety report. Furthermore, the intention is that registrants may save money by co-operating on the preparation of the dossier. The information is submitted by one lead registrant on behalf of the others, with the other joint registrants submitting other information (such as company details and production volume) separately. However, manufacturers and importers are allowed to opt out of the joint submissions of registration dossiers if this would result in excessive costs, if they disagree with the lead registrant on the interpretation of information or if disclosure of confidential information would cause substantial commercial damage.

To facilitate the transition to the REACH system, registration provision will be applied in a step-wise fashion as illustrated in the timeline in the diagram to the left.

Evaluation
The EU Chemicals Agency will undertake an evaluation of the technical dossier once in receipt of the registration application. The Agency may either approve the registration, request further information or may apply authorisations to certain uses in the case of the most hazardous substances.

The Agency will also conduct substance evaluations on a rolling programme of substances of high concern, which is also likely to lead to authorisations/restrictions on use.

Dossier evaluation involves:

• ECA will scrutinise all testing proposals primarily to ensure no unnecessary animal testing is carried out
• ECA will carry out a full compliance check of 5% of all registration dossiers
  
  Substance Evaluations will be carried out by:
• EU Member States and the EC will agree an annual list of substances to be assessed in-depth
• Competent Authorities will carry out substance evaluation, which may lead to new control measures or to no further action

Authorisation/Restriction
The burden of proof is placed on the applicant to demonstrate that the risk from the use of the substance is adequately controlled or that the socio-economic benefits outweigh the risks, taking account of available information on alternative substances or processes.

• all uses of substances of very high concern must be authorised (around 1500 substances)
  e.g. Carcinogenic, mutagenic or toxic for reproduction (CMRs)category 1 and 2, Persistent, bioaccumulative and toxic or very persistent and very bioaccumulative (PBTs/vPvBs)
• authorisation will only be granted if the risks of a substance are under ‘adequate control’
• if adequate control is not possible, authorisation may be granted on socio-economic grounds if there is not suitable safer alternative
• companies will be required to make efforts to fins safer substitutes as part of the authorisation process
• any substitute must deliver lower overall risks and be technically and economically feasible
• downstream users may use a substance for an authorised use provided they obtain the substance from a company to whom an authorisation has been granted and that they keep within the conditions of that authorisation. Such downstream users will need to notify the Agency that they are using an authorised substance.
  
  The Restrictions procedure places conditions on the manufacture or use of certain dangerous substances or the prohibition of these activities.
• any substance on its own, in a preparation or in an article may be subject to Community-wide restrictions if it is demonstrated that risks are not adequately controlled.
• certain existing restrictions are carried over in a consolidated version into the REACH Regulation (e.g. Asbestos, certain Azo-dyes, and POPs)

What substances are covered?
The REACH Regulations exempt certain substances that are adequately regulated under other legislation, like medicinal products, or that generally present such low risks as not to require registration, like water, oxygen, certain noble gases and cellulose pulp. In other cases natural occurring substances such as minerals, ores and ore concentrates, cement clinker etc. are not required to be registered as long as they are not chemically modified. Polymers are exempted as well from the requirement to register, since they usually are not very hazardous, but in certain circumstances monomers in polymers have to be registered. However, the registration of polymers may be reviewed later. The European Commission will review some of these exemptions, those contained in Annexes IV and V, within 12 months after entry into force of REACH.

European Chemicals Bureau http://ecb.jrc.it/ – is the focal point for data and the assessment procedure on dangerous chemicals. Information may be obtained from:

What do I Need to do?

REACH – What do I need to do?
It is important that you understand what your business needs to do under REACH in order to ensure compliance. Your responsibilities are dependent on whether you are an importer, manufacturer, distributor or user of substances AND the nature of the substances. Under the Regulations, the following definitions apply:

• Manufacturer – one who manufactures a substance in the EC (meaning the production or extraction of a substance in the natural state).
• Importer – one who is responsible for import into the EC.
• Distributor – one who only stores and places on the market a substance, on its own or in a preparation, for use by third parties.
• Manufacturers/Importers

Manufacturers/Importers of substances in quantities >1 t/yr will need to register that substance with the ECA in line with the timetable on page 7. In order to complete a registration, registrants will need to submit a Technical Dossier (p.8). The extent of that information depends on the hazardous nature of the substance as defined by the classification and labelling regulations and the volume manufactured/imported by the registrant. The details of the test data for the different classes of substances are contained in the annexes VII – X of the Regulation.

In addition to this test data substances manufactured/imported in >10 t/yr will require a Chemical Safety Report (p.8) to be conducted and the need to identify known uses and specify risk management controls for those uses. This will necessitate manufacturers consulting with their customers and other downstream users.

Chemical Users
If a chemical manufacturer/importer does not register a chemical for the particular application, then the onus for registration will fall on that chemical user to make the registration.

Chemical users, therefore, need to make sure that information on their uses is passed up the supply chain and is included in the registrant’s application as an identified use. They are obliged to provide the information necessary for the registrant to carry out risk assessments and to follow risk reduction management advice issued either in the registration or via an SDS (Safety Data Sheet) issued by their supplier.

If the chemical user produces preparations (i.e. chemical mixtures), it needs to assess the applicability of REACH to the individual components of those preparations.

Manufacturers of Finished Goods or Articles
REACH requires registration of those substances in articles which may be released during normal or foreseeable use. Therefore manufacturers of finished goods will need to assess the applicability of REACH to their products and ensure that the substances and applications are registered either as part of the registration by the manufacturer/ importer or by themselves.

Why use ISL Praxis?

ISL Praxis - REACH Services
The new Registration, Evaluation and Authorisation of Chemicals (REACH) Directive comes into force in Spring 2007. It will require significant action by all users of chemicals and will drive major changes throughout industry. All chemicals manufactured or imported into Europe in quantities over one tonne per annum will need to be registered by manufacturers and/or importers. This registration process requires that users of chemicals have a thorough understanding of the hazards, risk control measures and proposals to perform any outstanding tests.

Why Use ISL Praxis
We are a specialist environmental consultancy focused on industrial process and corporate regulation. We provide a range of services to help our clients improve their environmental performance and comply with environmental legislation. These include PPC permit assistance and carbon reduction services.

Our consultants are chemists and chemical engineers and combine experience of working in SMEs and multinational multi-site organisations. We also have experience of working with Regulatory organisations and can apply our understanding of regulatory interpretation to your benefit.

We have deliberately structured our company with our Consultants working regionally from home offices to provide UK-wide coverage at best cost. We have powerful IT systems located at our Birmingham head office which allows us to draw together the knowledge of our entire team. We pass on the cost savings associated with our low overheads to our clients.

We offer tailored solutions - we do not apply generic one-size-fits-all models. We will work collaboratively with you, helping you identify which parts of REACH compliance you can achieve in house and which parts you need our expert advice. We will help you along the path to full compliance with REACH in a friendly, effective and timely manner.

What ISL Praxis can do for you
The implications of REACH are entirely dependent on your business activity, as detailed on this web-site. It may involve a substantial amount of preparative work and has the potential to seriously impact your business activities. Imagine the impact to your business if a key raw material that you have used for decades suddenly became unavailable and you had not identified appropriate alternatives with the necessary supply chain.

ISL Praxis can help you no matter what your business activity. We offer the following services which will give you the confidence that your responsibilities under REACH are being appropriately managed and enable you to focus on your core business activities.

ISL Praxis REACH Toolbox

• Initial REACH Impact assessment: Are you in, or out?
• REACH Vulnerability Assessment: assessing vulnerability; level of existing preparedness; portfolio analysis; assessment of supply chain risks.
• Produce an inventory of substances and preparations, establishing annual usage
• Assess reliability of suppliers and potential benefits of alternative suppliers
• Preparation of Technical Dossiers
• Preparation of Chemical Safety Reports
• Preparation of Chemical Safety Assessments
• Act as your representative on consortia etc.
• Train your staff on the implications and methodologies for REACH compliance
• Provide technical assistance in regulatory negotiations

… and more; please ask for details of services that can meet your business needs in this area.

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