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GUIDANCE ON THE IMPLEMENTATION OF THE “CLP REGULATION” (EC REGULATION ON CLASSIFICATION, LABELLING AND PACKAGING OF SUBSTANCES AND MIXTURES EC 1272/2008) FOR PLANT PROTECTION PRODUCTS- AMENDED OCTOBER 2014

1. Introduction

1.1 This guidance provides advice on implementing the requirements of the EC Regulation on Classification, Labelling and Packaging of Substances and Mixtures (known as the CLP Regulation - EC 1272/2008) for plant protection products (PPPs). In the UK the CLP Regulation replaces the Chemicals (Hazard Information and Packaging for Supply) Regulations (CHIP).

1.2 The following guidance does not apply to adjuvants other than the general advice on the CLP Regulation in paras. 4 to 7 below,. Applicants who hold List Entries for adjuvants must comply with the requirements in CHIP or the CLP Regulation but CRD do not currently assess and include classification and labelling requirements in the List Entry. There is therefore no requirement for new classification and labelling to be notified to CRD.

1.3 Specific guidance for holders of Parallel Trade Permits for imported products are set out in para. 15 below.

2. Definitions of ‘classification’, labelling’ and ‘packaging’

2.1 Throughout this guidance these terms are defined as follows:

 ‘Classification’ refers to the supplier of a substance or a preparation/mixture evaluating the information identified in CHIP/CLP and applying it to the specified criteria for classification to ascertain the hazards associated with the substance or preparation/mixture. Under CLP this consists of the Hazard class/category and Hazard Statement.

 ‘Labelling’ refers to the supplier communicating the hazards of substances and mixtures via a label, the elements of which are set out in CHIP/CLP, to ensure appropriate protection of human health and the environment. Under CLP this includes the Signal word, Pictogram, Hazard Statements, Precautionary statements and Supplementary statements.;

 ‘Packaging’ refers to the supplier packaging a dangerous/hazardous product in line with the requirements of CHIP/CLP, to ensure appropriate protection of human health and the environment.

2.2 However, this guidance is concerned only with the ‘classification’ and ‘labelling’ of PPPs and how the requirements of CHIP and CLP impact on the authorisation and labelling of such products under the PPP Regulation (EC) No 1107/2009.

1 October 2014 3. What are the CHIP Regulations?

3.1 Since 31st July 2004 all PPPs have been included within the scope of the Chemicals (Hazard Information and Packaging for Supply) Regulations (CHIP) in the UK. The latest amendment is known as CHIP 4 and came into force on 6 April 2009.

3.2 CHIP implemented Directives 67/548/EEC (the ‘Dangerous Substances Directive’ - DSD) and 1999/45/EC (the ‘Dangerous Preparations Directive’ - DPD), which require that those responsible for the supply of substances and preparations (e.g. plant protection products) must classify and label the product with respect to physico-chemical properties, human health and environmental effects.

3.3 CHIP requires that certain symbols (and associated wording e.g. ‘Dangerous for the environment’) and ‘Risk’ (R) phrases are included on the product label to reflect the classification, along with appropriate ‘Safety’ (S) phrases to ensure safe use. There are several symbols and many R- and S-Phrases (see the HSE website) plus other labelling requirements required by CHIP.

4. What is the CLP Regulation?

4.1 The above Directives (DSD and DPD) are being gradually replaced by the CLP Regulation (EC 1272/2008) which came into force on 20th January 2009. This Regulation implements in all EU Member States the United Nations’ Globally Harmonised System (GHS) for classification and labelling. It introduces new classification criteria, hazard symbols (called ‘Hazard Pictograms’) and labelling phrases (known as ‘Hazard Statements’ and ‘Precautionary Statements’). Under CLP the term ‘substances’ retains its meaning but ‘mixtures’ is used in place of ‘preparations’. Further details can be found on the HSE website.

4.2 The CLP Regulation applies directly in all EU Member States, requiring no national transposition. Its provisions will be phased in over a number of years and it will come fully into force on 1st June 2015 by which point all PPPs being placed on the market must be classified and labelled in line with CLP. Until then a transitional period applies to allow gradual migration from CHIP to CLP.

5. What are your responsibilities in classifying and labelling of plant protection products?

It is the responsibility of the authorisation holder to ensure that the classification and labelling are correct and up-to-date based on all information available. You must always be in a position to defend the classification and labelling if required. All the relevant guidance on CHIP and CLP can be found on the HSE website using the links above.

6. What are the deadlines for changing to CLP?

6.1 The important dates in this transitional period for both substances and preparations/mixtures are as follows:

2 October 2014 (a) Substances (e.g. single component PPPs/adjuvants, active substances, co-formulants, synergists, safeners)

1st December Suppliers must classify substances according to both CHIP and 2010 to CLP. They must label and package substances according to 1st June 2015 CLP.

However, the re-labelling and re-packaging of substances which were already in the supply chain (‘on the shelves’) on the 1st December 2010 was postponed until 1 December 2012 (to avoid the unnecessary burdens of re-labelling and re-packaging whilst these substances filter through the supply chain).

1st June 2015 Suppliers must classify, label and package according to CLP onwards only.

(b) Preparations/mixtures (e.g. plant protection products and adjuvants other than those consisting of a single component)

20th January 2009 Suppliers must classify preparations/mixtures according to to 1st June 2015 CHIP (i.e. DPD) and may continue to label and package them according to Regulations 6 to 11 of CHIP.

However, as an alternative, they may also choose to classify the preparation/mixture in accordance with CLP (i.e. the product is classified in line with both CHIP and CLP). In this case, they must then label and package in accordance with CLP only (i.e. the labelling and packaging requirements of CHIP no longer apply).

1st June 2015 Suppliers must classify, label and package according to CLP onwards only.

However, the re-labelling and re-packaging of preparations/mixtures which are already in the supply chain (‘on the shelves’) on this date may be postponed until 1st June 2017 (to avoid the unnecessary burdens of re-labelling and re-packaging whilst these preparations/mixtures filter through the supply chain).

6.2 The latest CHIP Regulations (CHIP 4) align CHIP with the CLP transitional arrangements and include the necessary provisions for suppliers who choose to apply the CLP Regulation as an alternative to CHIP ahead of these mandatory compliance dates.

7. Under which legislation should you classify your PPP product?

7.1 Under the CHIP/CLP transitional arrangements it is currently up to you which legislation you use to classify and label your products until the deadlines for preparations/mixtures’ listed in para. 6.1(b).

7.2 Until 1st June 2015, you must continue to classify (and therefore label) a preparation/mixture (i.e. most PPPs) in accordance with CHIP. You may also choose to classify the product in accordance with CLP (as well as CHIP) and in such a case you must label in accordance with CLP.

3 October 2014 7.3 However, single component PPPs (i.e. a ‘substance’) must have been classified in line with both CLP and CHIP and labelled/packaged in line with CLP since 1st December 2010. This should be a rare case.

8. What should I do if I want to change to CLP during the transitional period?

8.1 For existing authorised products, if you now wish to amend your labelling to CLP you can usually do so without an application to change the authorisation. If you do so you must notify us of the CLP classification and labelling for our records- see para. 13 for full details.

8.2 However, you do have to consider whether the new classification would result in more restrictive conditions of use for the product as detailed in the authorisation (e.g. a requirement for more personal protective equipment). If it does, you will have to make an application for a change to the authorisation- see para. 14 for full details.

9. When will CRD make an assessment of the CHIP/CLP classification and labelling?

9.1 We will continue to normally only make a full assessment of the classification and labelling requirements when it is relevant to the application for authorisation under consideration, i.e. applications for:

 new products;  changes in existing formulations; and  re-registration of existing products.

9.2 Whereas we have previously accepted CHIP classifications during the transitional period, from October 2014, whenever you make an application for any of the above you must provide a classification proposal in line with CLP. to ensure that we issue new authorisations after 1st June 2015 with a CLP classification.

9.3 Please note that any classification proposed by CRD will be based on the most up-to-date information we have available. If new information/data subsequently requires a change to the classification and labelling specified in the authorisation then you can make the necessary changes without the need for a new application (unless the change has an adverse effect on the conditions of use in the authorisation- see paras. 12 and 14). However, you are always required to notify us of the change for our records- see para. 13.

10. How does the classification have to appear on a PPP label?

Guidance on drafting a PPP label and our suggested format for presenting CHIP/CLP classifications on authorised product labels is set out in our Labelling Handbook. You can use the same format if you intend to label under the CLP Regulation. Further advice on labelling in accordance with CLP is available in the ECHA guidance document.

4 October 2014 11. Will the classification and labelling appear on product authorisations?

11.1 As detailed in Regulatory Update: 20/2011 and in accordance with Regulation 1107/2009, we now issue new authorisations with details of the CHIP or CLP classification. This is based on the most up-to-date information we hold on our product files and could be one of the following:

 Where we have carried out a full assessment under CHIP or CLP , the classification will be as proposed by CRD.

 Where we have not fully assessed the classification (e.g. the product has not yet been re-registered) we will identify the classification and labelling from one of the following:

o If we have authorised a label since the implementation of CHIP or CLP, the classification from that authorised label will be specified on the authorisation.

o If the authorisation holder has notified a change from CHIP to CLP, or a change to the existing CHIP or CLP classification, we will use that classification.

o Where neither of the above apply we may base the classification on that specified in any notification submitted circa. October 2003 in response to All Approval Holders Letter 16/2002 ; i.e. where authorisation holders notified their proposed CHIP classifications for our records when the CHIP first encompassed PPPs.

o Where we cannot use any of the above it may be necessary to contact you for details of the product classification and this will be done via the normal procedure of requesting further information during an application.

We will not be taking retrospective action on existing product authorisations which do not include a classification and they will be updated with the classification as and when new product authorisations are issued as described above.

11.2 For products classified under CHIP, both the classification and labelling requirements appear on the authorisation (which will be published). This is because we previously included both in the label amendments section of the authorisation covering letter and it was logistically easier to simply transfer the same information to the authorisation.

11.3 However, for products classified under CLP we will:

 only include the classification on the authorisation (as required under Regulation 1107/2009), i.e. 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, i.e. Signal word, Pictogram,

5 October 2014 Hazard Statements, Precautionary statements and Supplementary statements. This will not be published.

12. Other than changing from CHIP to CLP, when else may you need to change the classification and labelling?

12.1 As explained under para. 3 the supplier has the ultimate responsibility for classifying and labelling a product and this includes ensuring that the classification is based on up-to-date information and the appropriate legislation. Other than reclassifying an existing product to meet the requirements of the CLP Regulation you may also need to change the CHIP or CLP classification and label in the following cases, e.g.:

 There is a classification change for any substance in the product (i.e. active substance, coformulant, safener or synergist) which leads to re- classification of the product. Annex VI of the CLP legislation (Regulation (EC) No 1272/2008) giving the agreed classifications for dangerous chemicals is regularly updated by Adaptations to Technical Progress (ATPs), e.g. Regulation (EC) 286/2011. You should be aware of these updates in respect of the classification of any a.s, 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 e.g. new mammalian toxicity or ecotoxicity data on the whole formulation or one of its components. Therefore, a change in classification may be required where newly generated data indicate that this is appropriate.

12.2 In rare cases, any of these changes may also affect the conditions of use in the authorisation and may require further action (see para. 14).

13. Do you need to inform CRD if you change the CHIP or CLP classification and labelling?

13.1 You may update the classification and labelling without an application for a new authorisation (including a change from CHIP to CLP) if the change does not adversely affect the conditions of the use of the product as set out in the authorisation(see para. 14).

13.2 We do not make an assessment of such changes and no immediate amendment of the authorisation is required. However, if you update your labels you are required under Article 31(2) Para 2 of Regulation 1107/2009 to immediately inform us. This information should be sent to [email protected] referencing the product name, MAPP number and details of the new classification and labelling and we will update our records (please title the email ‘NOTIFICATION OF CLASSIFICATION CHANGE FOR [product name]’.

13.3 You may also include the a new CLP notification at the same time as submitting an application for authorisation even if it is not one of the types where we will make a full assessment (i.e. new product/ formulation change/ re-registration- see para. 9 above). As long as the change is not ‘adverse’- (see para. 14 below) we will add it (without assessment) to the new Notice of Authorisation.

6 October 2014 13.4 In either case you should present the new classification and labelling details plus a justification where appropriate in the form of tables as set out in Appendix 1 (CHIP) and Appendix 2 (CLP) or similar. The next time a new authorisation is issued for any other reason we will revise the classification details in the authorisation.

14. What if a change in classification affects a condition of authorisation?

14.1 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 an operator risk assessment, e.g.:

 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: Very Toxic; Toxic; Corrosive; category 1 and 2 for carcinogenicity, mutagenicity or toxicity for reproduction; or where a risk assessment demonstrates that personal protective clothing (PPE) is required for safe use of the product (this usually means that products classified as skin sensitisers or risk of serious damage to eyes are unlikely to be authorised as home garden products). Please note that amateur products that fall outside these criteria (i.e. do not carry the above classifications and do not require PPE following our risk assessment) but require protective clothing under CHIP/CLP will continue to be authorised where appropriate.

14.2 Therefore, 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. Further information on adverse data and submission procedures can be found in the Applicant Guide.

15. Classification and labelling for Parallel Trade Permit products

15.1 Parallel Trade Permit Holders must comply with CHIP/CLP requirements and ensure that that their product is classified and labelled under CHIP or CLP until 1 June 2015 and only CLP for stocks entering the supply chain after 1 June 2015 .

15.2 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 CHIP/CLP classification and labelling from the UK ‘reference product’. Therefore, for CHIP-classified products they must wait for the change to CLP labelling on the reference product before they can relabel as

7 October 2014 required by 1st June 2015. Permit Holders should notify us when the change has been made in line with the requirements in para. 13.2 above.

15.3 For Permits issued prior to October 2014 we have issued an Amendment Notice amending the conditions of labelling to allow these changes. to be made in line with the reference product. New Parallel Trade Permits issued from October 2014 include the new conditions of labelling to allow the change.

8 October 2014 Appendix 1 Suggested template for notification of new CHIP Classification and Labelling

Proposed new classification and labelling under the Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 (CHIP) for [Product] MAPP XXXX.

Symbol indication of danger Justification (including details of previous classification if different) Dangerous for the environment e.g.

Risk (R) Phrase(s) Justification (including details of previous classification if different) e.g. R52 Harmful to aquatic organisms

Safety (S) Phrase(s) Justification

e.g. S57 Use appropriate containment to avoid environmental contamination

9 October 2014 Appendix 2 Suggested template for notification of new CLP Classification and Labelling

Proposed new classification and labelling under the CLP Regulation (EC) 1272/2008 for [Product] MAPP XXXXX

Change to CLP from previous CHIP classification Change from existing CLP classification

Classification

Hazard Class and Category Justification (including details of previous classification if different) e.g. Acute toxicity hazard category 1

Hazard Statement(s) Justification (including details of previous Code Phrase classification if different) e.g. H303 May be harmful if swallowed

Labelling

Signal word Justification i.e. Warning or Danger

Pictogram Pictogram code Justification e.g. GHS06

Hazard Statement(s) Justification Code Phrase e.g. H303 May be harmful if swallowed

Precautionary statement(s) Justification Code Phrase e.g. P361 Remove/Take off immediately all contaminated clothing

Supplementary statement(s) Justification Code Phrase e.g. EUH401 To avoid risks to man and the environment comply with the instructions for use

10 October 2014 Important note

Please complete the sections on CLP ‘Classification’ and ‘Labelling’ as fully as possible with all the requested information as it is required for our authorisations. In particular, ensure that all ‘Hazard Classes/Categories’ are included under ‘Classification’.

This is especially important where H-Statements arising from a certain Hazard Class/Category are not included on the label but we need to know that the product has that classification; e.g. the most common example is where a product is classified as both:

 Acute Aquatic Acute 1 (H400 Very toxic to aquatic life); and  Aquatic Chronic 1 (H410 Very toxic to aquatic life with long lasting effects).

In such cases H400 is omitted from the label as it is covered by H410.

Where this happens, It is essential that under ‘Classification you include:

 both Hazard Classes and Categories (‘Acute Aquatic Acute 1’ and ‘Aquatic Chronic 1’); plus  both Hazard Statements (H400 ‘Very toxic to aquatic life’ and H410 ‘Very toxic to aquatic life with long lasting effects’).

However, under ‘Labelling you should only include H410 in the ‘Hazard Statement’ box.

11 October 2014

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