Well-proven know-how

knoell in the UK

With Dr. Knoell Consult and Cyton Triveritas we've got you covered in the United Kingdom.

knoell UK

Crop Protection, Chemicals & Biocides

Dr. Knoell Consult Ltd. provides services mainly for registration of chemicals, crop protection products and biocides. Working with both European and non-European clients, the small but  very experienced team is perfectly set-up not only to support you with in the traditional markets, but also to guide you through the uncertain times of a regulatory landscape post Brexit (also see our post-Brexit regulatory summary below).

Dr. Knoell Consult Ltd.
22 Cathedral Road | Cardiff CF11 9LJ

 The route to us
Photo of Dr. Iain A. MacKinnon
Dr Iain A. MacKinnon
Managing Director
  •   +44 29 2034 9880
  •   +44 29 2034 9889
  •   send email

Animal Health

knoell is bringing all of its Animal Health CRO expertise and service brands under one name: As of February 2021, Cyton as well as Triveritas became knoell, creating one animal health team based in the US, EU, China and the UK.

Cyton Biosciences Ltd.. specialises in the registration of veterinary pharmaceuticals and animal feeds.

Cyton Biosciences Ltd.
68 Macrae Road Eden Office Park Ham Green | Bristol BS20 0DD

 The route to us

 

Triveritas joined Cyton in 2020 and complements our services with their proven track record of conducting global veterinary clinical trials to GCP and VICH standards. Triveritas have over two decades' experience supporting client companies in the areas of veterinary regulatory affairs, scientific writing and global project management.

knoell Animal Health Ltd.
Bank Barn | How Mill | Brampton CA8 9JY

Photo of Helen Edwards
Helen Edwards
Managing Director
  •   +44 117 973-9244
  •   +44 127 537-3281
  •   send email
Photo of Dr. Karolina Bate
Dr Karolina Bate
Managing Director
  •   +44 117 906-7642
  •   +44 127 537-3281
  •   send email

UK post Brexit

Now that the UK has left the EU and the implementation (or transition) period during which the UK has been following EU rules and regulations ends on 31 December 2020, there will be consequences for companies manufacturing or importing into the UK. However, to what extent your products might be affected depends on the regulatory framework that applies.

 

Chemicals

A standalone chemicals regulation, commonly referred to as UK REACH, will come into force from 1 January 2021 in Great Britain (GB: England, Scotland, Wales). Under the Northern Ireland Protocol, the process for Northern Ireland businesses will not change after 1 January 2021: (EU) REACH will still apply. UK REACH will be administered by the UK’s Health & Safety Executive (HSE). UK REACH is closely based on (EU) REACH but will be an entirely separate regulatory regime so may diverge in future. Transitional arrangements to allow companies to comply with UK REACH will apply during 2021 and for some years thereafter.

Consequences of this include:

  • Substances which are manufactured in or imported into both GB and EU would require two separate registrations, under both UK REACH and (EU) REACH.
  • GB companies purchasing substances from the EU, even though these substances are registered under (EU) REACH, will become importers under UK REACH with obligations to register the substances in GB. These obligations could be alleviated if the EU supplier were to appoint an Only Representative (OR) based in GB.
  • Companies based outside the EEA using an OR who is based in GB to cover imports into the EU will need a new OR based in the EU. Conversely, companies based outside the EEA using an OR based in the EU to cover imports into GB will need a new OR based in GB. In short, non-EEA/non-GB companies may need two ORs: one for GB and one for the EU!
  • There will also be standalone GB regulations corresponding to CLP and PIC.

With affiliates based in GB and EU, as well as many years of experience acting as OR for non-EEA companies selling into the EEA, knoell is well placed to support clients in maintaining their business and fulfilling their regulatory duties once UK REACH comes into force.

Download our factsheet here.

We can act as OR...

  • for GB manufacturers or non-EEA suppliers selling into the EU via knoell NL and knoell Germany.
  • for EU or non-EEA suppliers selling into GB, including submitting notifications and registrations to the HSE and preparing registration dossiers as appropriate via knoell UK.

 

Biocides

From 1 January 2021, the EU biocides legislation (BPR) will no longer apply if your biocidal products or active substances are placed on the GB market. As mentioned above, under the Northern Ireland Protocol, the process for Northern Ireland businesses will not change after 1 January 2021.

Similar to the consequences outlined for Chemicals above,

  • GB based companies will have to apply to the UK HSE if they wish to apply for an active substance to be approved, or for a biocidal product to be authorised, in GB.
  • GB based manufacturers or suppliers of biocides/biocidal products wishing to market within the EU have to either be located in the EU or have an appointed EU-based representative to be listed in Article 95 list of substances and suppliers. A GB version of the EU list of approved active substance suppliers will be created and operate in parallel to the EU Article 95 list from 1 January 2021.
  • EU or non-EEA manufacturers and suppliers selling into GB will require either a company located in GB or a representative to obtain authorisation via UK HSE.
     

Plan ahead:

We can help you make appropriate contingency plans based on your individual circumstances and then be ready to support you with the new separate regulatory regime.

 

Plant Protection Products

Most recent information available states that from 1st January 2021 the current EU regulatory regime for Plant Protection Products (PPPs) will be converted into GB-wide regulations which will remain very similar to the existing EU regime. As mentioned above, under the Northern Ireland Protocol, the process for Northern Ireland businesses will not change after 1 January 2021 and EU PPP legislation will continue to apply. After this point, EU decisions on active substances and Maximum Residue Levels (MRLs) will no longer apply to GB. HSE will continue to act as the national regulator UK-wide and will make its own decisions on active substance approvals, PPP authorisations and set MRLs based on its own assessments. Applicants will need to make separate applications under the GB and EU regimes to obtain access to both markets. There will be a GB list of approved active substances and MRLs.

Existing PPP authorisations remain valid in GB until their current expiry date.

In contrast to other regulatory frameworks (e.g. Chemicals and Biocides), companies will not need local representation to obtain authorisation for their active substances and products in GB or EU. Also, the current active substance approvals, PPP authorisations, and Maximum Residue Levels (MRLs) will remain valid in GB and EU after exit day and therefore immediate action is not required.

 

Veterinary Medicines

With animal health teams in both the EU and the UK, knoell can offer our clients a full range of services in product development and regulatory affairs to meet the requirements for both regions. For further information have a look at the knoell s Animal Health page "UK beyond Brexit".

Updates from the UK

spalten3

REACH: Current Landscape and Emerging Issues

27 Apr 2021
online event

This online event will cover topics around the UK’s new chemicals legislation with a focus on UK REACH.

EMA news: pre-submission requests under Reg 2019/6, AMR updates and guidance for vaccine development

In the latest EMA news review there are updates on pre-submission requests under Reg 2019/6, AMR and guidance for vaccine development

company news

Cyton and Triveritas become knoell

As of February 2021, Cyton and Triveritas will become knoell which creates one animal health team based in the US, EU, China, and the UK.