REACH
What is REACH?
• European Union regulation concerning Registration, Evaluation,
Authorisation and restriction of Chemicals
• Aims:
– To provide a high level of protection of human health and the environment from
the use of chemicals
– To make manufacturers and importers who place chemicals on the market
responsible for understanding and managing the risks associated with their use
– To allow the free movement of chemicals 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 the hazardous
properties of substances and read across of data
REACH Requirements
• REACH applies to substances manufactured or imported into the EU
in quantities of 1 tonne per year or more
• REACH requires manufacturers and importers of substances to
register them with the European Chemicals Agency (ECHA)
• It is illegal to manufacture or supply substances that have not been
registered (unless substance exemptions apply)
REACH Requirements
• Registration takes place by means of a registration dossier which
must be provided to ECHA
• Manufacturers and importers must collect and collate specified sets
of information on properties of substances they manufacture or
supply at or above 1 tonne per year
• REACH will ensure very high risk substances are adequately
controlled and progressively substituted by safer
substances/technologies or only used where there is an overall
benefit for society
General Registration Dossier
• General Registrant Information
• Substance Identification
• Substance Manufacture & Use
• Classification & Labelling
• Guidance on Safe Use Concerning
• Exposure Information
• Physiochemical Properties
• Toxicological Information
• Ecotoxicological Information
• Methods of Detection And Analysis
REACH Requirements
• Manufactures and importers must provide downstream users with
the risk information needed to use the substance safely
• This is done via classification and labelling and Safety Data Sheets
(SDS) where needed
Information required in SDS
1. Substance & Company Identification
2. Hazards Identification
3. Compositional Information
4. First Aid Measures
5. Fire Fighting Measures
6. Accidental Release Measures
7. Handling & Storage Information
8. Exposure Controls/Personal Protection
9. Physical & Chemical Properties
10. Stability & Reactivity
11. Toxicological Information
12. Ecological Information
13. Disposal Considerations
14. Transport Information
15. Regulatory Information
16. Other Information
REACH Requirements
• The following materials are exempted from REACH:
– Specific substances listed under Annex IV of Regulation (see: http://www.reach-
compliance.eu/english/legislation/reach-exemptions.html)
– Substances covered by Annex V (includes substances which occur in nature, if they are not chemically
modified, including natural gas, LPG, crude oil)
– Monomers bound into polymers (but registration required if monomer present at ≥ 2% w/w in the polymer
and is at ≥ 1 tonne per annum)
– Polymers
– Food & food ingredients
– Waste and certain recycled materials
– Substances needed in the interests of defence
• Petroleum substances (except sulphur) are recognised by REACH as substances of
“Unknown or Variable composition, Complex reaction products or Biological
materials” (“UVCBs”)
• Petroleum products and blendstocks imported in quantities in excess of 1 tonne per
annum are generally not exempted and will all need to be registered – Concawe have
undertaken a programme of risk assessment of petroleum substances, including
development of risk assessment methodologies to which members have access –
see link at end of talk
REACH Implementation Timeline
DATE TARGET
01/06/07 REACH comes into force
01/06/08 ECHA becomes operational
01/06/08 to Pre-registration period (during which substances already being manufactured and
30/11/08 supplied (“Phase-in” substances) are “pre-registered” (without a full registration dossier)
to give extended registration deadlines)
01/12/08 Registration for existing substances (that have not been pre-registered) begins
01/01/09 List of pre-registered substances published and Substance Information Exchange
Forum (SIEF) formed
01/12/10 Phase 1 – Deadline for registration for pre-registered “phase-in” substances supplied at
greater than or equal to 1000 tonnes per annum (also ≥ 100 tonnes/annum if classed
under CHIP* as very toxic to aquatic organisms and ≥ 1 tonne/annum if classed under
CHIP* as Cat 1 or Cat 2 carcinogens, mutagens or reproductive toxicants)
01/06/13 Phase 2 – Deadline for registration of substances supplied at greater than or equal to
100 tonnes per annum
01/06/18 Phase 3 – Deadline for registration of substances supplied at greater than or equal to 1
tonne per annum
*CHIP = Chemical Hazard Information and Packaging for Supply regulations
MTD REACH Services
• Education
– Training on nature of different commodities, production processes, additives
– Significance of chemical & physical testing
• Testing Services
– Full product survey
– Compositional Testing for Registration Dossier
– Physiochemical Testing
• Company Product Survey
– Identification of all products and other materials (e.g. Additives) shipped at quantities > 1 tonne per annum
– Production of reference specifications
– Guidelines for independent inspectors
• Safety Data Sheet Preparation
– Compositional data
– Handling & Storage Information
– Exposure Controls/Personal Protection
– Physical & Chemical Properties
Useful Links
• European Chemicals Agency Website:
http://echa.europa.eu/
• EU REACH Document:
http://www.hse.gov.uk/REACH/resources/regulation.pdf
• Concawe:
http://www.concawe.be/Content/Default.asp
(Oil Companies’ European Association for Environment, Health &
Safety in Refining & Distribution)