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REACH Regulation / EU REACH Services
REACH (Registration, Evaluation, Authorisation and Restriction of Chemical Substances) was written to ensure that all chemicals on the market in the European Union (EU) do not adversely affect human health or the environment. The REACH Regulation was enacted by the EU in June of 2007.
The 3rd and final deadline, of May 31, 2018, for the registration of phase-in substances, 1-100 tonnes, is fast approaching. BioReliance testing services fully comply with assay needs and designs, as outlined in the REACH regulation and compliance guidelines, to measure Toxicological Information (the mutagenicity, genotoxicity, or toxicity of chemicals). BioReliance focuses on testing for mutagenicity and focused toxicity studies. Thus we are your reliable source to evaluate and navigate the intricate testing paradigms required for REACH registration.
Consult with one of our experts to determine the toxicology assays that are best for your REACH compliance needs or use the search tool to the right to browse our offerings.
About REACH Regulation
- EU REACH Regulation set forth seven objectives that chemical manufacturers must meet:
- Protection of human health and environment
- Maintenance and enhancement of the competitiveness of the EU chemical industry
- Prevention of fragmentation of the internal market
- Increased transparency
- Integration with international efforts
- Promotion of non-animal testing
- Conformity with EU international obligations under the WTO
Consult with one of our REACH compliance experts to explore how BioReliance’s toxicology testing can help.
Available Assays and Services for EU REACH Testing
BioReliance offers an extensive array of testing services to assist in all phases of the REACH regulation including a broad spectrum of in vitro and in vivo toxicology testing services designed in accordance with REACH guidelines. All REACH testing assays are conducted in full compliance with all applicable guidelines and GLP regulations.
Under section 8 in the Annexes of the information, required Toxicological Information is outlined. In section 8.4, Mutagenicity testing assays are listed, which call for a tiered approach to toxicological assessment of substances. Further, under section 8.5 and 8.6 Acute Toxicity and Repeated Dose Toxicity assays are noted. Although the approach and procedures for testing are outlined, the interpretation of results and navigation of testing options requires expertise and experience. BioReliance has assembled the foremost collection of scientists available anywhere and thus you can rely on us to assist in your REACH testing needs.
Below is a list of assays outlined in the regulation. Please consult a BioReliance scientist for assistance in proper assay selection.
Assay | OECD | REACH | Primary |
Genetic Toxicology Assays (Mutagenicity) | |||
IN VITRO GENE MUTATION STUDY IN BACTERIA | VII | ||
Ames Assay | 471 | B13/14 |
|
IN VITRO GENE MUTATION STUDY IN MAMMALIAN CELLS | VIII | ||
Mouse Lymphoma Assay | 476 | B17 |
|
CHO/HGPRT Gene Mutation Assay | 476 | B17 | |
Syrian Hamster Embryo Transformation Assay |
| B21 | |
IN VITRO CYTOGENETICS | VIII | ||
Chromosomal Aberration Assay | 473 | B10 |
|
Micronucleus Assay | 487 | N/A | |
DNA DAMAGE AND REPAIR |
| ||
In Vitro Unscheduled DNA Synthesis | 482 | B18 |
|
In Vitro Sister Chromatid Exchange (SCE) Assay | 479 | B19 | |
IN VIVO CYTOGENETICS | IX | ||
In Vivo Micronucleus Assay | 474 | B12 |
|
Metaphase Analysis | 475 | B11 | |
IN VIVO DNA DAMAGE AND REPAIR |
| ||
Rat Liver UDS Assay | 486 | B39 |
|
Mammalian Toxicology Assays |
| ||
ACUTE TOXICITY | VII | ||
Acute Oral Toxicity – Fixed Dose | 420 | B1 |
|
Acute Toxicity (Dermal) | 434 | B3 |
|
REPEATED DOSE | VIII | ||
Repeated Dose (28 Day) Toxicity (Oral) | 407 | B7 |
|
Repeated Dose (28 Day) Toxicity (Dermal) | 410 | B9 | |
SUB CHRONIC | IX | ||
Sub-chronic Repeated-Dose Oral Toxicity 90-Day (Rodent) | 408 | B26 |
|
Sub-chronic Repeated-Dose Oral Toxicity 90-Day (Rabbit) | 409 | B27 | |
Sub-chronic Repeated-Dose Dermal Toxicity 90-Day | 411 | B28 |
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