Classification and Labelling of Plant Protection Products
In June 2015, the Classification, Labelling and Packaging Regulation, No. 1272/2009, known as CLP, became fully operational in Europe for all chemicals, including plant protection products, PPP and biocides BP . All products placed on the market thereafter will need to comply, and the Regulation will be the key driver for the harmonised labelling of all PPP, biocide and chemical mixtures across Europe.
The CLP Regulation came into force on 20 January 2009. It will replace the Dangerous Substances Directive 67/548/EEC (DSD) and the Dangerous Preparations Directive 1999/45/EC (DPD) in a stepwise approach through a transitional period that extends until June 2015. In addition CLP implements the 2nd edition of the United Nations Globally Harmonised System of classification and labelling of chemicals (GHS) into EU law. The CLP Regulation uses many of the building blocks of GHS, that aims to describe and communicate the same hazards in the same way around the world.
The changes in labelling of substances has already been implemented since 2010 and those dealing with plant protection substances will already be familiar with the significant changes in the what are known as ‘pictograms’ or danger symbols and the Risk and Safety phrases, R&S.
From June 2015 all products being placed on the market will be required to conform to the requirements of CLP including the new “pictograms” or hazard symbols, the new Signal Words, Hazard Statements, Precautionary Statements and Product Identifiers.
Through 2014, manufacturers and suppliers of chemical products were switching to the new labelling.
CLP Regulation – Key dates towards implementation
On 1 June 2015, the CLP Regulation became fully operational. Before that time, transitional measures were applied (Article 61).
Substances (PPP active substances)
From 1 December 2010 until 1 June 2015 substances were classified in accordance with both the DSD and the CLP Regulation, but labelled and packaged in accordance with the CLP Regulation.
Where a substance was already classified, labelled and packaged according to the requirements of the DSD and placed on the market before 1 December 2010 (i.e. it is already in the supply chain by that date) the manufacturer, importer or distributor may postpone its re-labelling and re-packaging according to the CLP requirements until 1 December 2012.
Mixtures (PPP Products)
For mixtures, the deadline for classification, labelling and packaging according to the requirements of the CLP rules was 1 June 2015. Prior to that date, they should have been classified, labelled and packaged according to DPD. In cases where a mixture has already been classified, labelled and packaged according to CLP before 1 June 2015, only the CLP label shall appear, and not the label according to DPD.
Where a mixture is already classified, labelled and packaged according to the requirements of the DPD rules and placed on the market before 1 June 2015, (i.e. it is already in the supply chain by that date), the manufacturer, importer, downstream user or distributor may postpone its re-labelling and repackaging according to the requirements of the CLP rules until 1 June 2017.
As we’ve passed 1 June 2015 , more and more PPPs have appeared with the new CLP label. ECPA and its member companies have been committed to a smooth and seamless process of re-labelling and will continue communicating with all its stakeholders through the supply chain.
What the new labelling looks like?
- Pictograms: The traditional orange and black danger symbols are now replaced by red and white diamonds in which are depicted the hazards.
- Signal word: This now indicates the severity of the hazard e.g. “Danger” and replaces the previous classification statements e.g. “Toxic”.
- Hazard Statements: Up to five hazard statements are now allowed as compared to fours risk phrases under the old DSD.
- Precautionary Statements: A variety of precautionary statements can now be used.
- Additional labelling: PPPs being regulated under the new authorisation Regulation 1107/2009 may also need to carry additional risk management labelling such as information on buffer zones, re-entry periods and harvest intervals.
Whilst the definition of certain hazards may changed and the associated wording, the risks remain the same and as such do not alter the effective use of any product.
A typical example of a product label
CLP Implementation under the PPP Regulation 1107/2009
The CLP Regulation requires that manufacturers and suppliers of mixtures classify and label their products according to the properties of the mixture. This is known as ‘self classification’.
Competent authorities accountable for the implementation of CLP are also responsible for the enforcement of CLP and monitoring of products in the market place.
Unfortunately, under the PPP Regulation 1107/2009, Article 31 specifies through that the authorisation granted by the competent authority shall include a classification and as such is interpreted that Member States will decide on the classification when granting the authorisation.
ECPA believes that the CLP Regulation takes precedence over the PPP regulation with respect to classification and labelling, however some, but not all of the competent authorities dealing with PPPs would disagree that the responsibility for labelling should lie with the manufacturer or supplier. This has led to a confusing situation between Member States in that some are requesting almost a re-submission of data with the new classification and others are happily to let companies re-classify and re-label without recourse to the authorisation and simply refer to the Safety Data Sheet, SDS. See ECPA’s position on self classification of PPPs.
ECPA has developed a suitable template to help companies with their submissions to competent authorities.
We have also answered some specific questions about how CLP is applied in the crop protection industry in our Frequently Asked Questions.
Many people have produced a lot of good quality supporting information. Here are our favourites:
- ECHA Introductory Guidance to the CLP regulation
- ECHA Guidance on the Application of the CLP Criteria
- ECHA Guidance on labelling and packaging in accordance of Regulation (EC) 1272/2008
- ECHA Guidance on the compilation of Safety Data Sheets
- ECHA Guidance on Downstream Users
- ECHA FAQ
- DUCC (The downstream users of chemicals coordination group)
- The CLP regulations and ATPs
Article 36 of the CLP Regulation stipulates that substances that show carcinogenic, mutagenic or reprotoxic properties, or are respiratory sensitisiers should be subject to a harmonised classification process.
Article 36 (2) applies to substances that are used as PPP and BP active ingredients and determines that that be subject to a harmonised classification procedure for all classification end-points.
Unfortunately, any PPP substance going for a harmonised classification has to be submitted to ECHA and the Risk Assessment Committee through a Member State competent authority and such competent authorities are not always aligned nationally with their counterparts dealing with PPP approvals.
The process is not too dissimilar to that used previously under the Joint Research Committee of the Commission and their Technical Committee on Classification & Labelling, although the process has been tightened up, such that RAC must deliver an opinion on harmonised classification within 18 months of an application, and that industry input is restricted to a one-off public consultation.
EFSA and ECHA are currently looking at ways to align their respective processes such that a CLH opinion can be concluded during the evaluation timeline for authorisation of an active substance.
The Classification & Labelling (C&L) Inventory is a database that contains basic classification and labelling information on notified substances received from manufacturers and importers. Whilst there are numerous PPP substances in the data base, ECPA believes that most are adequately represented and classified appropriately, unlike many general chemical substances.