21 November, 2018

How to avoid obstacles with REACH Annexes VII-X

By Dr. David Howes

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The standard information requirements for a substance outline the minimum data needed as part of a REACH registration dossier. The data describes the physicochemical, toxicological, environmental fate and ecotoxicological properties of the substance on which ECHA can make a decision regarding the safety of the substance. Data requirements vary with the amount of substance used, with additional, more complex information required as you manufacture or import more of your substance into the EU/EEA

A brief history

The information requirements for REACH evolved out of the previous NONS (notification of new substances) 
legislation for chemical registration. REACH provides a legal framework that mandates data sharing across 
companies manufacturing or importing the same substance promotes the reduction of animal testing and 
engages more transparently with the wider public.

CPC Periodic table of elements and laboratory tools. Science 133382660

Tonnage bands and data requirements

REACH has four tonnage bands governed by different annexes:

  • 1–10 tonnes/year – Annex VII
  • 10–100 tonnes/year – Annex VIII
  • 100–1,000 tonnes/year – Annex IX
  • >1,000 tonnes/year – Annex X.

Under REACH, applicants are now required to conduct a one-generation reproductive toxicity study (OECD test guideline 443) when preparing chemical dossiers discover more in our informative e-book.

Annex VII

The data requirements for Annex VII are the simplest, focusing on key physicochemical properties, such as the substance’s vapour pressure, water solubility and flammability. It also includes assessments for short-term ecotoxicology endpoints like aquatic toxicity and biodegradation and for the toxicology endpoints of in vitro skin and eye irritation, skin corrosion and sensitization, mutagenicity and acute toxicity.

Only the latter endpoint of acute toxicity requires testing on vertebrate animals. If you can make the case for your substance in the 1-10 tonne band being of low risk, you can benefit from reduced information requirements where only data on physicochemical properties are necessary.

Annex VIII

Annex VIII builds on the Annex VII requirements with further toxicology endpoints – some of which require in vivo data, such as short-term repeated dose studies (28 days), a reproductive/developmental toxicity screening test – further tests for mutagenicity, ecotoxicity and environmental fate.

Annex IX and X

Annexes IX and X add more complex and long-term studies for, toxicology, ecotoxicology, and environmental fate endpoints. Annex IX covers 90-day repeated dose, extended one generation reproductive toxicity and pre-natal development toxicity studies as well as long term aquatic toxicity, biodegradation and bioaccumulation tests. Testing on terrestrial species is introduced at this tonnage band with short-term toxicity testing on invertebrates, plants and microorganisms a requirement.

Annex IX tests further extends the testing requirements with studies for reproductive and developmental toxicity on second species, a test for carcinogenicity and long-term testing on terrestrial species. 

If you have a substance falling under Annex IX and X requirements, you need to take into account the testing already undertaken at Annex VII and VIII

 

If you have a substance falling under Annex IX and X requirements, you need to take into account the testing already undertaken at Annex VII and VIII. Some tests are also driven by the outcome of the chemical safety assessment; others are performed in a tiered manner, all of which affects your testing strategy.

As for the lower tonnage bands, the use of alternative test strategies is possible for the higher tonnage bands. For example, use of read across, chemical categories, weight of evidence and Quantitative structure–activity relationship (QSAR) models. However, there are fewer opportunities to use such approaches with the more complex endpoints.  More commonly, you will need to adopt a well thought-out, logical, testing strategy to deliver the most resource and animal-efficient testing plan.

Any tests involving animals at Annex IX and X cannot be conducted without first submitting a testing proposal to the European Chemicals Agency (ECHA) within your dossier. The test proposal is reviewed by the ECHA Member State Committee and decisions made available to the general public and any other interested third parties, in line with REACH’s stated aim of openness and transparency.

What to consider

Consider the following to establish the testing approach that is right for your substance: 

  • Let the science drive the testing and follow a logical and considered approach
  • Know your substance’s properties, many chemical exhibit unique behaviour
  • Be familiar with the test methods, understand their objective, methodology, outcome and understand limitations
  • Wherever possible follow ECHA Endpoint Specific Guidance
  • Take heed of the advice in ECHA document Application of the CLP Criteria
  • Always consider alternative methods to reduce the use of animals 

Conclusions

To successfully navigate the data requirements for different tonnage bands, you need to have an in depth understanding of your substance’s properties and usage, combined with expert technical and regulatory knowledge into how to meet REACH requirements.

Helping you stay one step ahead of your registrations

Do you know what’s required to bring your active substance to the global market?  Is your product portfolio data robust enough to meet a guideline?  From interpreting complex local regulations through to a complete dossier submission, we partner with you to ensure your chemical reaches the lives of the people, animals and the environment it’s been designed to enhance.  We’ve been doing so for over 60 years.

Looking to discover more?

The last REACH deadline was in May 2018 and brought to a close the period of active information gathering on the safety of chemical products marketed in the EU/EEA. It has resulted in a massive database of safety information on a wide range of substances, and heralds an exciting new phase of evolution in scientific and regulatory thinking. So, with the data in, the decision letters start to roll out. We’ve put together an informative blog to help answer these questions and many more.

ECHA decision letters - Your guide to all you nee to know Read the blog

About the author

Dr David Howes provides high-quality regulatory and scientific advice to customers who wish to achieve regulatory compliance in the industrial chemicals sector. He is also involved with the EU REACH regulation on chemicals; and global regulatory submissions. During his 30 years at Envigo he has been involved in pesticide residue analysis, environmental analysis, physicochemical testing, product chemistry and regulatory affairs.

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Category // REACH, Chemical, higher tier testing