What are REACH & CLP?
REACH provides a timetable for substance Registration based on the inherent hazard and production volume of each substance. The first deadline was for substances manufactured or imported at greater than 1000 tonnes per year, or which were considered to be carcinogenic, mutagenic or reprotoxic (CMR) at volumes of ≥ 1 tonne per year, or were classified as R50/R53 at volumes of ≥ 10 tonnes per year. The deadline for the Registration of these substances was by 1st December 2010. During this first phase of registration 3801 substances were registered as either full registrations, on-site isolated intermediates, or transported isolated intermediates. A second phase of registration was completed by 1st June 2013 for substances manufactured or imported by a company at >100 to 1000 tonnes per year. The final registration phase for phase-in substances is scheduled for completion by 1st June 2018 for substances manufactured or imported by a company at >1 to 100 tonnes per year.
The four basic Registration steps identified in the REACH Regulations are:
- Step 1 – Gather and share existing information
- Step 2 – Consider information needs
- Step 3 – Identify information gaps
- Step 4 – Generate new data/propose testing strategy
Each manufacturer, importer or “only representative” (of manufacturers based outside the EU) is individually obliged to submit a separate Registration for each of his substances. However, registrants for the same substance must jointly submit information on its hazardous properties, classification and labeling, future testing proposals, and safe uses via a lead registrant who is selected through discussion amongst all registrants. The Substance Information Exchange Forum (SIEF) is the main mechanism for sharing data for phase-in substances after pre-registration. The “inquiry process” is the mechanism used for non phase-in substances.
Manufacturers or importers of substances above 1 tonne per year must submit a technical dossier electronically to ECHA. Submission must be via IUCLID 5 software and must contain information on:
- Manufacturer/importer identity
- Substance identity, manufacture and use
- Substance classification and labelling
- Safe use guidance
- Substance intrinsic properties in the form of robust summaries
- Whether the above information has been reviewed by an assessor
- Proposals for further testing, if relevant
- Main use categories, type of uses, and significant routes of exposure (for substances registered in quantities of 1 to 10 tonnes per year)
Manufacturers or importers of substances above 10 tonnes per year must submit a Chemical Safety Report (CSR) to ECHA, which documents a Chemical Safety Assessment (CSA) for the substance. If the substance is classified as Dangerous, or Persistent, Bioaccumulative and Toxic (PBT), or very Persistent and very Bioaccumulative (vPvB), an exposure assessment needs to be performed, using exposure scenarios. ECHA has been working on standardizing the approach and format of the exposure scenarios included in the submitted CSRs, for example by developing the Chemical Safety Assessment and Reporting (CHESAR) tool to enable registrants to carry out their safety assessments in a structured, harmonized, and efficient way. The tool uses substance-specific data directly imported from IUCLID and reports exposure and risk calculation results which can then be imported directly back into IUCLID for submission to ECHA.
Annex VI of REACH is applicable for all substances. The required information is as follows:
- REACH Annex VI information Requirements
- General information on the Registrant (e.g. name, address, contact person, production sites, etc.)
- Substance identity (e.g. name, EINECS/CAS #, formula, impurities, etc.)
- Manufacture & use (e.g. overall manufacture, form supplied to downstream users, waste quantities, unsafe uses, etc.)
- Classification & labelling (e.g. hazard classification, specific concentration limits, etc.)
- Guidance on safe use (e.g. Safety Data Sheet information)
- Exposure (use category, use specification, significant routes of human & environmental exposure, exposure pattern)
In addition to the Annex VI information requirements, the following hazard data are required for substances, depending on the manufacture or imported volume of the substance (tonnage band):
|> 1000 tonnes/year||100-1000 tonnes/year||10-100 tonnes/year||1-10 tonnes/year*||REACH Annex VII Physicochemical properties (e.g. melting & boiling point, solubility, octanol-water partitioning, explosivity, etc.)Toxicology (skin & eye irritation, skin sensitisation, mutagenicity, acute toxicity)Ecotoxicology (acute toxicity to invertebrates, algal growth inhibition, ready biodegradability)|
|REACH Annex VIII Toxicology (repeated dose toxicity, reproductive toxicity, toxicokinetics)Ecotoxicology (acute fish toxicity, sludge respiration, hydrolysis, sorption)|
|REACH Annex IX Physicochemical properties (stability in organic solvents, dissociation constant, viscosity)Toxicology (further repeated dose & reproductive toxicity tests)Ecotoxicology (long term invertebrate & fish tests; degradation in water, soil & sediment; fish bioaccumulation; tests with terrestrial invertebrates, plants & microbes)|
|REACH Annex X Toxicology (further reproduction studies, carcinogenicity study)Ecotoxicology (further degradation, fate & behaviour studies; long term toxicity to terrestrial invertebrates & plants, & to aquatic sediment organisms; long term toxicity to birds)|
* REACH Annex III on identifying CMRs and dangerous substances also applies to substances in this tonnage range
With expert argument it is possible to adapt or avoid the tests identified in the Table above if testing does not appear to be scientifically necessary (e.g., it is possible to use alternative non-testing approaches such as QSAR and read-across, or weight of evidence from existing studies), or if testing is not technically possible, or an exposure assessment for the specific substances suggests that particular tests for a hazard are not required.
Registrants needed to notify ECHA electronically by 1st December 2010 about Classification and Labeling of a substance alone or in a preparation that is placed on the market and for which a Registration had not already been submitted. This had to be done if the substance met criteria for classification as dangerous under Directive 67/548/EEC (the Directive on Classification, Packaging and Labeling of Dangerous Substances) or exceeded concentration limits in Directive 1999/45/EC if present in a preparation. ECHA collated all information received into a Classification and Labeling Inventory which identifies whether registrants and notifiers differ in their labeling or classification for the same substance. If this occurs, the registrants and notifiers are required to make every effort to come to an agreed classification.