Plant Protection Products Regulations 1107/2009
What this means for your business
- Enforced by
- The Crown Estate, Crown Estate Scotland, APHA, Forestry Commission, Natural England
- Applies to
- United Kingdom
- On this page
- 32 compliance obligations, 1 practical guide
What you must do
32 compliance obligations under this legislation.
Risk assessment 2
Demonstrate compliance to obtain product authorisation
Before you can sell a pesticide in Great Britain you must prove it meets a long list of safety and quality standards – approved active ingredients, unchanged specifications, acceptable co‑formulants, limited user exposure, and reliable data on residues, impurities and physical‑chemical properties. You need to provide official test results and documentation showing these requirements are satisfied as part of your authorisation application.
Submit data for equivalence assessment of active substances
Unlimited fineIf you change the source or the way an active ingredient, safener or synergist is made for a plant protection product, you must give all the required technical data to every authority that will check whether the new version is equivalent to the original. You also have to reply to any comments the authority asks for during their review.
Management duties 11
Avoid duplicate testing when applying for plant protection product authorisation
If you plan to apply for, renew or review an authorisation for a plant protection product, you must first check whether the same active substance has already been approved and request any existing test reports. You also need to share the identity and impurity data of your substance and cooperate with current holders to agree on sharing protected test data, so you don’t repeat work that’s already been done.
Comply with conditions and restrictions on PPP approval
If your business holds an approval for a plant protection product, you must follow all conditions attached to that approval. This includes meeting purity and impurity limits, respecting usage restrictions, providing any confirmatory information the regulator asks for, and putting in place risk‑mitigation and monitoring after the product is used.
Ensure plant protection product advertising complies with the law
If your business advertises any plant protection product (e.g., fungicide, insecticide, herbicide), you must only promote products that are authorised, include the required safety message, avoid any claim that could mislead about health or environmental risk, and never show unsafe use or omit the required warning symbols. Follow any media‑specific restrictions that the authority may impose.
Ensure product labels meet CLP and any national requirements
When you put a plant protection product on the UK market, you must make sure its label shows the correct hazard classification, labelling and packaging info required by the CLP Regulation and any extra UK rules. If the competent authority asks, you also need to supply sample packaging, label drafts or leaflets before the product is authorised.
Obtain authorisation before placing or using plant protection products
If your business sells or uses a plant protection product in the UK, you must have that product authorised by the relevant competent authority first. The only times you can skip authorisation are if the product contains only basic substances, is for research/development, is already authorised elsewhere and is being moved for export, or you have a parallel‑trade permit. Check the authorisation status or apply for it before you put the product on the market or use it.
Only place or use authorised adjuvants
You must not sell or use any adjuvant (add‑on product for pesticides) in the UK unless it has been granted authorisation under the Plant Protection Products Regulations. Before you market or apply an adjuvant, check that it has the required authorisation and keep proof of that authorisation on file.
Package plant protection products to prevent mistaken consumption
If you place any plant protection product or adjuvant on the market that could be confused with food, drink or animal feed, you must use packaging that makes that mistake unlikely. When the product is sold to the general public, the packaging must also contain something (e.g., a bittering agent) that discourages anyone from eating or drinking it. The same safety rules that apply to hazardous chemicals also apply to these products.
Provide required label and documents for treated seeds
If you sell or supply seeds that have been treated with a plant‑protection product, you must make sure the seed label and any accompanying paperwork list the product name, its active ingredients, the standard safety‑precaution statements and any risk‑mitigation measures required by the authorisation. This information has to be present before the seeds are placed on the market.
Share vertebrate animal test data and pay fair share of costs
When you apply to register a plant protection product, you must first check that any required vertebrate‑animal tests have not already been done elsewhere and that you cannot use non‑animal methods. You must then try to share the existing test reports with any other companies that already hold authorisations for the same active ingredient and only pay your proportion of the cost of the information you need. If you cannot reach an agreement on cost sharing, you must tell the competent authority.
Submit required information for pesticide authorisation on time
When you apply for authorisation of a plant protection product, the authority has 12 months to decide. If they ask for more information they’ll give you up to six months to supply it. You must provide the requested details within that period or your application will be rejected as inadmissible.
Use only plant protection products that pass the comparative assessment
If your company makes, sells or uses plant protection products that contain a substance flagged as a ‘candidate for substitution’, you must only use it where a safer alternative is not already available. You must keep the authorisation and any renewal notices, and accept any restrictions imposed by the regulator.
Record keeping 1
Keep records of plant protection products and their use
If your business produces, imports, exports, stores or sells plant protection products, you must retain records of those products for at least five years. If you are a professional user (e.g., a farmer or contractor applying the products), you must keep details of each application – product name, date, dose, area and crop – for at least three years. You must hand these records to the competent authority (or other authorised parties) when they ask for them.
Registration and licensing 7
Apply and submit a plant protection product authorisation application
If you want to sell a pesticide, herbicide or any plant protection product in the UK you need to go through an authorisation process. This means preparing a full application with up‑to‑date scientific and technical data and any required risk‑mitigation information, and submitting it to the competent authority. The authority will examine your data objectively and will inform you of any conditions or a refusal.
Apply for and implement minor‑use extensions for plant protection products
If your company holds an authorisation for a plant protection product and you want to use it for a new minor use, you must apply to the competent authority with all required data (residue levels, risk assessments, etc.). If the authority grants the extension, you must update the product’s labelling as instructed; if you refuse, the authority will have to inform users directly.
Apply for authorisation of plant protection products
If you want to sell or use a pesticide, insecticide or other plant protection product, you must get an authorisation from the competent authority. That means submitting an application with the required documents and following the conditions the authority sets. Without authorisation you cannot legally market or use the product.
Apply to reinstate your parallel trade permit
If you held a parallel trade permit that expired on 1 January 2023, you must submit a reinstatement application to the competent authority by 1 April 2024, providing the original paperwork, confirming the product is still authorised and its label unchanged, and supplying photos of the container. The authority will only grant the permit if all information is complete and the product remains authorised.
Get your plant protection product authorised before marketing
If you want to market or use a plant protection product, you must first apply for and receive formal authorisation from the relevant authority. The company that produces, imports or sells the product is responsible for this application. Once authorised you can legally place the product on the market or use it in work.
Submit application for plant protection product authorisation
If you want to sell a plant protection product in the UK (or change an existing authorisation), you must apply to the competent authority. Your application must include detailed product and active‑substance dossiers, safety justifications, a draft label and, on request, product samples. You can also ask that parts of the dossier be kept confidential.
Submit renewal application for active‑substance approval
If you produce an active substance used in plant protection products, you must send a renewal application to the relevant authority at least three years before the current approval ends. The application must list any new data you plan to submit, show why it’s needed, include a timetable for new studies, and identify any confidential or data‑protected information. You also have to supply the full application to other authorities if they request it.
Reporting and filing 11
Include required documents when applying for mutual recognition of a plant protection product
If you want to have a plant protection product recognised in the UK under Article 42A, you must submit an application that includes four specific documents: the authorisation copy from the reference authority, a statement that your product is identical, the required dossier (full or summary), and the reference authority’s assessment report. Failing to attach any of these means your application will be incomplete and could be rejected.
Notify authorities of new safety concerns and report annually on product performance
If you hold an authorisation for a plant protection product, you must tell the authority that granted the authorisation straight away when you learn of any new information that suggests the product may be harmful, ineffective or no longer meets the required standards. You also have to send an annual report on any loss of efficacy, resistance issues or unexpected effects on plants, the environment or health.
Provide additional studies or information to the authority
If the competent authority reviewing your plant‑protection product asks for more data, you must supply the requested studies or information within the deadline they set – up to a maximum of six months. Failing to do so can delay or stop the approval process for your active substance.
Provide evidence when requesting confidentiality of submitted information
If you submit data to the Plant Protection Products Regulations and want it kept confidential, you must show proof that releasing the information would damage your commercial interests or breach privacy. Without such evidence, the regulator will treat the data as public.
Provide information and samples to the assessing authority on time
When the authority asks for more information, an updated dossier or samples of your product, you must supply them within the time limits set (usually 90 days). If you want to comment on the draft assessment report, you have 60 days to send your written remarks. Failing to do so can delay or prevent approval of your plant protection product.
Provide required documents to authority when asked
If your business applies for authorisation of a plant protection product, you must be ready to supply copies of all the paperwork listed in Articles 33(3) and 34 to the competent authority whenever they request it. This enables the authority to compile a complete file and share it with other authorities as needed.
Provide required product data when exempt from submitting test reports
If you are applying for authorisation of a plant protection product and you are allowed to skip the usual test‑study reports because the authority already holds them, you still must give the regulator full details of the product – its composition, a declaration that no prohibited co‑formulants are used, and information on the active substance(s). You also have to supply additional data if the authority asks you to show that your product works like the one whose data you are accessing.
Renew plant protection product authorisation
When the approval for an active ingredient in your plant protection product is renewed, you must also renew the product’s authorisation. You need to apply for renewal and, within three months, provide the authorities with the required documentation and any new data. Failure to do so may delay the continuation of your product on the market.
Submit a complete dossier for PPP approval
If you want to market a plant protection product (e.g., pesticide) in the UK, you must prepare a detailed dossier showing that the active substance meets the approval criteria. The dossier must include summaries of all test data, animal‑testing justifications, a checklist of required items, any maximum residue level (MRL) applications, and recent peer‑reviewed studies.
Submit complete application dossiers and respond to authority requests
When you apply for a plant protection product you must send all the required documents listed in the Regulations. If the authority tells you something is missing you have up to three months to provide it, otherwise the application will be rejected. If the authority confirms the application is admissible, you must also forward the dossiers to any other competent authorities that ask for them.
Submit required documents with plant protection product authorisation application
If you want to market a pesticide or other plant protection product in the UK, you must attach specific paperwork to your application – a copy of the foreign authorisation (with an English translation if required), a statement that your product is identical to the authorised one, the full or summary dossier, and the reference‑state assessment report. The authorities will then decide your application within 120 days.
Penalties for non-compliance
1 penalty under this legislation. 1 carry an unlimited fine.
Submit data for equivalence assessment of active substances
Unlimited fine
Practical guidance
Our guides explain how to comply with the requirements above.
Sections and provisions
103 classified provisions from this legislation.
Duties 43
- s.6 Conditions and restrictions
- s.8 Dossiers It
- s.9 Admissibility of the application the assessing competent authority
- s.10 Access to the summary dossier
- s.11 Draft assessment report
- s.12 Conclusion by the assessing competent authority updated dossier
- s.15 Application for renewal data protection claims pursuant
- s.16 Access to the information for renewal
- s.28 Authorisation for placing on the market and use authorisation
- s.29 Requirements for the authorisation for placing on the market
- s.33 Application for authorisation or amendment of an authorisation
- s.34 Exemption from the submission of studies constituent territory
- s.36 Examination for authorisation
- s.37 Period for examination
- s.38 Assessment of equivalence under Article 29(1)(b)
- s.39 Reporting and exchange of information on applications for authorisation file
- s.41 Authorisation
- s.42 Procedure
- s.43 Renewal of authorisation information required
- s.49 Placing on the market of treated seeds A competent authority
- ... and 23 more duties
Powers 15
- s.13 Approval Decision
- s.17 Extension of approval period for the duration of the procedure
- s.18 Work programme
- s.19 Implementing measures
- s.20 Renewal decision
- s.21 Review of approval
- s.23 Approval criteria for basic substances
- s.30 Provisional authorisations
- s.44 Withdrawal or amendment of an authorisation
- s.45 Withdrawal or amendment of an authorisation at the request of the authorisation holder
- s.46 Grace period
- s.69 Emergency measures
- s.77 Guidance documents
- s.78 Amendments and implementing measures
- Review of basic substance approval Review of basic substance approval
Definitions 9
- s.1 Subject matter and purpose
- s.2 Scope
- s.22 Low-risk active substances
- s.24 Candidates for substitution
- s.35 Competent authority examining the application
- s.47 Placing on the market of low-risk plant protection products
- Application and interpretation Application and interpretation
- Definitions: competent authority, constituent terr Definitions: competent authority, constituent territory and appropriate authority the appropriate authority
- Regulations Regulations
Exemptions 8
- s.3 Definitions: general
- s.4 Approval criteria for active substances
- s.27 Co-formulants
- s.48 Placing on the market and use of plant protection products containing a genetically modified organism
- s.53 Emergency situations in plant protection
- s.54 Research and development
- s.59 Data protection
- Procedure and criteria for the approval of active Procedure and criteria for the approval of active substances, safeners and synergists pursuant to Chapter II