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The Applicant Guide: General Information On Re-Registration And Step 1

What is re-registration?

Once an active substance has been approved under Article 80 of Regulation (EC) 1107/2009 (formerly known as inclusion in Annex I of Council Directive 91/414/EEC), Member States (MS) must re-evaluate plant protection products in accordance  with the Uniform Principles, on the basis of dossiers satisfying the active substance and product data requirements. We refer to this process as re-registration.

Please note that re-registration procedures do not apply to renewal of product authorisations in accordance with Article 43 of Regulation (EC) 1107/2009, which will be subject to separate procedures.

Products containing existing active substances

For products containing existing active substances approved under national legislation (The Control of Pesticide Regulations (as amended) 1986 (COPR )) (now deemed to be authorised under Regulation EC 1107/2009 in accordance to National Rules), re-registration marks the transition to regulation under Community legislation, Plant Protection Products Regulations (EC) 1107/2009. Data packages (or dossiers) previously submitted in support of these products need to be updated and an assessment carried out to the EC harmonised standards.

Products containing new active substances

For products containing new active substances, re-registration requires the conversion of National Provisional Authorisations, issued pending a decision on approval of the active substance being taken, to standard authorisations.

What are the stages in this process?

There are two key stages in the re-registration process:

What happens after a decision is taken regarding approval of the active substance?

Once a positive opinion on approval of a new active substance has been delivered by the Standing Committee on the Food Chain and Animal Health (SCoFCAH), the European Commission (EC )) formally adopts the opinion and a Commission Directive (Inclusion Directive) is published in the Official Journal of the European Communities.

The Commission Implementing Regulation (formerly known as the Inclusion Directive) prescribes conditions that must be met and action that must be taken by MS within an agreed timeframe. There are 3 key dates:

The entry into force date

The Commission Implementing Regulation (formerly known as the Inclusion Directive) will specify an entry into force date which is the date when the active substance is actually approved.

The compliance deadline

The compliance deadline falls 6 months after the entry into force date. By this deadline, Member States must review all authorisations containing the approved active substance and ensure that products comply with approval conditions.

Member States are also required to ensure that their nationally authorised products are supported by an appropriate active substance dossier of data (studies/information). Where necessary, authorisations must be amended or withdrawn by this date.

The final deadline

The final deadline is the date by which all products containing only the approved active substance, or the approved active substance together with one or more other active substances which are already approved, must be re-evaluated in accordance with the Uniform Principles, on the basis of dossiers satisfying the requirements of Annexes II and III.

This date is usually four years after the entry into force date for existing active substances and 18 months after the entry into force date for new active substances.

A longer timeframe is allowed to re-register products containing existing active substances (eg those approved under National Rules) to give companies the opportunity to update their dossiers in line with the harmonised EC requirements, and to allow Member States sufficient time to complete the re-evaluation process.

What deadlines does CRD set for re-registration?

Following publication of a Commission Implementing Regulation (formerly known as the Inclusion Directive), we will establish administrative deadlines to ensure that the dates in the Directive are complied with as follows:

24 months before the final date set by the Commission for products containing an existing active substance to be re-registered ; or

12 months before the final date for products containing new active substances.

How will I know what the deadlines are and the action I will need to take?

After an active substance is approved, we will inform authorisation holders for products containing that active substance via a Regulatory Update published on our website, explaining the impact of the decision on their products, the action that they must take and the deadlines that will apply for re-registration.

Some aspects of re-registration may be harmonised at Community level with one Member State conducting some elements of the process on behalf of all others. If this is the case, we will also identify what action the authorisation holder is required to take.

Growers or grower groups responsible for existing PPPR 'Extensions of Authorisation for Minor Use' EAMU Authorisations, and holders of permits for parallel imported products,will also be informed via a Regulatory Update published on our website of the implications following from the inclusion decision. Others may request details from our Applicant Enquiry Team.

Details of deadlines and actions required can be found on our website under Re-registration requirements for existing UK authorisation holders.

A table of all active substance inclusions and their associated deadlines is also provided either alphabetically or in date order.

What if my product contains more than one active substance?

If your product contains more than one active substance, you will need to meet the corresponding Step 1 deadlines for each active substance.

However, you will not need to submit a re-registration application until all the active substances in your product have been approved. The deadline for Step 2 will be the latest one according to the timetables set for re-registration in the appropriate Implementing Regulation.

What do I need to do at Step 1?

The first stage of the re-registration process applies to all products containing that active substance.

Products containing existing active substances

For products containing existing active substances, detailed guidance meeting Step 1is available see: Re-registration requirements for existing UK Authorisation Holders.

Meeting Approval conditions

For each product you will need to demonstrate that the conditions of the approval are met. For example, you will need to demonstrate that:

You will occasionally need to meet other restrictions at this stage.

Demonstrating access to an active substance dossier

At Step 1, we will also ask you to provide information to demonstrate that your products are supported by access to an active substance dossier. You can do this in a number of ways:

  1. By referencing information and/or studies submitted to support inclusion in Annex I which are not protected in accordance with Article 80 of Regulation (EC) 1107/2009; or,
  2. By providing evidence of access to the information and/or studies submitted to support approval, which are protected in accordance with Article 80 of Regulation (EC) 1107/2009. These studies will be listed in Appendix III of the review report supporting the approval. or,
  3. By providing alternative and equivalent information/studies, including published studies, to those protected; or,
  4. By providing a case justifying why certain information/studies are not relevant to the uses which you wish to support.

Options (a) and (c) will only apply to addressing active substance requirements for existing active substances. Arrangements are in place to ensure that tests involving vertebrates are not repeated unnecessarily. Details of this procedure are given on the following page: The Applicant Guide: The Protection Of Data.

How should I present this information?

You do not need to submit a formal application at this stage. The requirements for presenting and submitting information are specified in CRD's post inclusion information available on this website.

You must submit the required information with a covering letter to the project manager in Pesticides Branch (as detailed in the Regulatory update published on our website), clearly listing the products being supported.

Any letters of authorisation allowing access to active substance data will need to be appropriately signed and dated. We will not accept photocopies.

Can I submit information after CRD's Step 1 deadline?

If you cannot meet the Step 1 administrative deadline for the submission of all the required information, you should contact the project manager to explain the reason for your delay. We may be able to establish a later deadline for the delayed part of the submission, providing this still leaves sufficient time for us to carry out the required checks by the compliance deadline.

What do we do at Step 1 and what happens if I meet Step 1?

After the Step 1 administrative deadline, we will assess submissions that have been received.

We will contact you before the Commission compliance deadline and let you know the outcome of our assessment:

What happens if I do not meet Step 1?

We will withdraw your authorisation with effect from the compliance deadline. From this date you (or your agents) will not be able to place any further stocks into the supply chain. However, others will have 6 months to continue advertising, selling and supplying stocks already in the supply chain and a total period of 18 months from the compliance deadline will be allowed for storage and use by any person.

How would I re-instate my authorisation after failing to meet Step 1?

Products containing one or more than one active substance, all of which are included in Annex I

You must make an application for standard authorisation. You must demonstrate how your product complies with the conditions of the approval and also provide dossiers satisfying the active substance and products data requirements . However, you can reference any information previously submitted at Step 1 and will not need to submit this information again.

Products containing more than one active substance, with at least one active substance not approved

You would still be able to make an application under National Rules. You must demonstrate how your product complies with the conditions of the approval and also provide active substance dossier(s) for active substances already approved. However, you can reference any information previously submitted at Step 1 and do not need to submit this information again.

To address requirements for active substances not yet approved and product related requirements, you will be able to refer to information supporting the previous National authorisation.

What if I wish to make changes to my National Rules Authorisation after approval but before the completion of the overall re-registration process ?

Under the transitional arrangements, apart from some exceptions, we cannot issue new National Authorisations for products containing approved active substances after the appropriate Implementing Regulation (Inclusion Directive) has entered into force. This is because the derogation to national legislation only applies until an active substance has been approved, after which Regulation (EU) 1107/2009 applies.

For more detail see the section on this website dealing with these 'Transitional Arrangements'.

Products containing new active substances

This stage is a much simpler one for products containing new active substances, since there will only be one source of the active substance/data owner and all the active substance data should already have been assessed for the purpose of approval.

Meeting Approval conditions

See Meeting Approval conditions for existing active substances.

Demonstrating access to active substance dossier

As for existing active substances, at Step 1 we will also ask you to provide information to demonstrate that your products are supported by access to an active substance dossier.

How do I present this information?

See How should I present this information for existing active substances.

Can I submit information after CRD's Step 1 deadline?

Yes, but you will need to contact the project manager to explain the reasons for your delay. We may be able to establish a later deadline for the delayed part of the submission, providing this still leaves sufficient time for us to carry out the required checks by the compliance deadline.

What happens if I meet Step 1?

Your existing authorisation will continue to the final deadline.

What happens if I do not meet Step 1?

We will issue a Notice withdrawing your authorisation. This will take effect from the compliance deadline.

From this date you (or your agents) will not be able to place any further stocks into the supply chain. However, others will have 6 months to continue advertising, selling and supplying stocks already in the supply chain and a total period of 18 months from the compliance deadline will be allowed for storage and use by any person.

How would I re-instate my authorisation after failing to meet Step 1?

See How would I re-instate my authorisation after failing to meet Step 1? for existing active substances.

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Further information

Updated 2017-01-06