Notification of changes to plant protection products under CLP Regulation

Responsibility for classifying and labelling

It is the responsibility of the authorisation holder to ensure that the classification and labelling of a product are correct and up-to-date based on all currently available information and the appropriate legislation.

You must always be in a position to defend the classification and labelling if required.

Classification requirements for a product label

Guidance on drafting a product label and our suggested format for presenting CLP classifications on authorised product labels is set out in our Labelling Handbook.

Further advice on labelling in accordance with CLP is available on the ECHA website.

Classification and labelling on product authorisations

In accordance with Regulation 1107/2009, all new authorisations will be issued with details of the CLP classification. This is based on the most up-to-date information we hold on our product files.

Where we:

have carried out a full assessment under CLP, the classification will be as proposed by HSE
have not fully assessed the classification we will identify the classification and labelling either from your classification and labelling notification or via a request for additional information

For product authorisations classified under CLP we will:

only include the classification on the authorisation (as required under Regulation 1107/2009), that is the hazard class/category and hazard statement - this will be published on our website
include the labelling requirements in the confidential Appendix 3 of the labelling section of the authorisation, that is the signal word, pictogram , hazard statements, precautionary statements and supplementary statements - this will not be published

Changes to the classification and labelling

The authorisation holder has the ultimate responsibility for classifying and labelling a product. You may need to change the CLP classification and labelling in the following cases:

If there is a classification change for any substance in the product (that is, active substance, co-formulant, safener or synergist) which leads to re-classification of the product. Annex VI of the CLP legislation (Regulation No 1272/2008) giving the agreed classifications for dangerous chemicals is regularly updated by Adaptations to Technical Progress (ATPs), for example, Regulation (EC) 286/2011. You should be aware of these updates in respect of the classification of any active substance, co-formulant, safener or synergist in your products, and revise the classification and labelling phrases as appropriate.
The classification of a product may also be determined using, for example, new mammalian toxicity or ecotoxicity data on the whole formulation but noting the rules regarding vertebrate tests. A change in classification may therefore be required where newly generated data indicate that this is appropriate.

Changes to classification that affect a condition of authorisation

Certain parts of our risk assessment for authorisation of a product and therefore the conditions of use listed in the authorisation take into account the classification of the product. Any changes to these may therefore affect the outcome of a non-dietary risk assessment, for example:

For professional products a more severe classification may lead to additional personal protective equipment (PPE) required in the ‘Operator Protection’ section of the label ‘Precautions’ and on the authorisation
For amateur products, a more severe classification may mean that the product is no longer acceptable for amateur use. Authorisation will not be given if the product would be classified as any of the following:
- Category 1, 2 or 3 for acute toxicity
- Category 1 (1A or 1B) for carcinogenicity, mutagenicity, reproductive toxicity or Specific Target Organ Toxicity (STOT SE/RE)
- Category 1 (1A, 1B or 1C) for skin corrosion
- Category 1 for eye damage
- Category 1, 1A or 1B for skin sensitisation

Or where a risk assessment demonstrates that personal protective clothing (PPE) is required for safe use of the product.

Please note that amateur products that fall outside these criteria (that is, do not carry the above classifications and do not require PPE following our risk assessment) but require protective clothing under CLP will continue to be authorised where appropriate.

Informing HSE of classification and labelling changes

Changes that adversely affect the risk assessment

Although it is likely to be a rare case, you must always consider whether any classification change would lead to more restrictive conditions of use or even no authorisation.

Such situations are considered to be ‘adverse’ and as an authorisation holder you have an ongoing obligation to immediately submit any new data and/or information on the potentially dangerous effects of an active substance and/or product.

Adverse data notifications for pesticide products.

Changes that do not adversely affect the risk assessment

You may update the classification and labelling without submitting an application for a new authorisation (provided the change does not adversely affect the risk assessment and conditions of the use of the product as set out in the product authorisation).

Label updates

If you update your labels you are required under Article 31(2) Para 2 of Regulation 1107/2009 to immediately inform us.

How to notify HSE

Email the information to [email protected] – insert in the subject line ‘NOTIFICATION OF CLASSIFICATION CHANGE FOR [PRODUCT NAME, MAPP])’

We suggest you provide the information using the template for notification of new/changed CLP Classification and Labelling .

HSE assessment

Beyond checking that the risk assessment is not adversely affected, we do not make an assessment of such changes and no immediate amendment of the authorisation is required. We will add the new CLP (without assessment) to the next new notice of authorisation.

Classification and labelling for parallel trade permit products

Parallel trade permit holders must comply with CLP requirements and ensure that their product is classified and labelled according to CLP.

However, permit holders cannot classify their product themselves as they are unaware of the full PPP formulation details. The permit requires that they use the identical CLP classification and labelling from the UK ‘reference product’.

Classification and labelling for adjuvants

Applicants who hold List Entries for adjuvants must comply with the requirements in the CLP Regulation, but HSE does not currently assess and include classification and labelling requirements in the list entry. There is therefore no requirement for new adjuvant classification and labelling to be notified to HSE.