An Introduction to Active Substance Approval and Product Authorisation
Changes due to Brexit
Your health and safety responsibilities will not change when the UK leaves the EU. This guidance is under review.
Under Regulation (EC) No 1107/2009 only authorised plant protection products can be advertised, sold, supplied, stored and used.
The authorisation status of products and conditions of use can change at short notice so you should check HSE's website to ensure products are being applied in accordance with current requirements. See Databases for plant protection products.
The process and standards required to obtain product authorisations are set out in EU legislation (Regulation (EC) No. 1107/2009 and associated guidance). See this link to the EU website for the EU legislation on plant protection products. This legislation applies in all EU Member States. However, national legislation is needed to underpin its operation and to introduce new fees and charges to replace the previous fees legislation. These provisions were implemented by the following legislation:
- Plant Protection Products Regulations 2011;
- Plant Protection Products Regulations (Northern Ireland) 2011; and
- Plant Protection Products (Fees and Charges) Regulations 2011.
The EU system establishes a two-tier registration system: Approval of active substances and authorisation of formulated products.
Approval of active substances
In the first stage of the registration system, active substances are assessed at EU level for approval.
The registration process assesses: the impact on workers applying the product, consumers of treated produce, residents living adjacent to application sites and others who may be passing-by at the time of treatment; whether and how the pesticide might move throughout the environment once it has been applied; the impact on the environment, in particular water bodies and wildlife; and product efficacy.
Further information about the approval process for active substances:
Approved Active Substances:
Active substances that have been shown to be without unacceptable risk to people or the environment are added to the list of approved active substances, which can be found on the EU database:
Renewal of approval of active substances
Active substances are initially approved for a fixed period (usually 10 years). If they are to remain approved after that period, they must be re-assessed to ensure that they continue to be without unacceptable risk to people or the environment according to the latest standards of assessment.
Renewal of active substances is organised in phased programmes depending on the expiry date of the approval. Further information about the renewal process can be found on the EU website and the UK overview:
If active substances are not renewed, they are withdrawn and Member States must withdraw any plant protection products containing those active substances from the market.
If active substances are renewed, the approval period is extended and existing authorisations of plant protection products containing those active substances must also be renewed by the Member States where they are already authorised.
Authorisation of formulated products
After approval of an active substance at EU level, companies can apply to Member States for authorisation to market formulated plant protection products containing that active substance.
Further information about the authorisation process of plant protection products:
The authorisation states the situation (for example crops or areas) in which the product can be used. It will also contain conditions, such as: the amount of product which can be applied, timing of application and time which must elapse between treating and harvesting crops or allowing people into treated areas; and any additional measures necessary for those responsible for applying the product to protect workers, residents and bystanders and the environment.
The conditions of authorisation are replicated on product labels. It is important that users understand and comply with the label.
There are different types of authorisations. Most typically, products are authorised for either professional (commercial) or amateur (home and allotment) use.
Information on registering plant protection products in the UK can be found on this website: link to product registration on the HSE website.
These are substances predominantly used for other purposes, but which can be approved for use for plant protection purposes. They are assessed at EU level and, if approved, do not require authorisation at Member State level. Information about basic substances can be found at this link to the EU website. Approved basic substances can also be found on the EU database.
We also have UK guidance on Basic Substance approval.
These are substances or preparations used to enhance the effectiveness of plant protection products. Further information about adjuvants can be found on this website link to adjuvant information.
Derogations under Article 28 not requiring an authorisation
In response to the derogations contained in Article 28(2)(c) and (d) in Regulation (EC) No 1107/2009, HSE is working with industry to establish an appropriate inspection regime to enable the derogations to apply in the UK.
Older national legislation that still applies
A small number of agricultural pesticides used for plant protection purposes continue to be regulated under the Control of Pesticides Regulations 1986 (COPR, as amended). Such pesticides include the commodity substances and products used to generate ethylene in situ (to control fruit ripening). Information about COPR can be found on the relevant pages. For a list of commodity substances still approved under COPR see HSE's databases.