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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
Guideline

REACH
Test Method

 Primary
REACH Annex

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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