5 July 2002
Classification and Labelling: Chemicals (Hazard Information and Packaging for Supply) (CHIP 3) Regulations and the Dangerous Preparations Directive (99/45/EC)
Background
Directive 99/45/EC, relating to the classification, packaging and labelling of dangerous preparations, repeals both the present Dangerous Preparations Directive (88/379/EEC) and Directive 78/631/EEC concerning the classification, packaging and labelling of pesticide preparations. Member states must adopt Directive 99/45/EC by 31 July 2002 for general preparations, and by 31 July 2004 for pesticide and biocidal products (covered by Directives 91/414/EEC and 98/8/EC respectively). The aim of the new Directive is to achieve a uniform approach to the classification and labelling of most dangerous preparations (there are some exemptions e.g. medicinal and veterinary products).
The Health and Safety Executive (HSE) is to implement Directive 99/45/EC by a new set of Chemicals (Hazard Information and Packaging for Supply) Regulations (CHIP 3) that are due to come into force this month. The CHIP 3 Regulations will be accompanied by a package of supporting documents, including new editions of the ‘Approved Supply List’ (ASL) and ‘Approved Classification and Labelling Guide’ (ACLG). Further useful details, including an overview and frequently asked questions, are given on HSE’s CHIP web-site at:
www.hse.gov.uk/chip/index.htm.
Important note (added to this document after issue date): new classification and labelling legislation (‘CHIP 4’) came into force on 6 April 2009. Further information is available on the HSE's CHIP website and Labelling Handbook contents page
Adjuvant Products
Adjuvant marketing companies should note that their products come under the definition of general preparations and should therefore be reclassified and labelled if necessary as soon as possible. Approval holders should also ensure that any adjuvants that they market are classified and labelled appropriately.
You may find it helpful to refer to HSE’s CHIP web-site (details given above). This explains that suppliers should do all they can to ensure that products comply with the law by 31 July 2002. However, HSE recognises that for some time after this date there may be old stock in the supply chain, hence CHIP 3 will include a due diligence defence.
Changes for Pesticide Products
The main changes to classification and labelling for pesticide products under Directive 99/45/EC are as follows:
- No differentiation between liquid and solid pesticide formulations when assessing acute oral and dermal toxicity;
- Different criteria for inhalation toxicity;
- Classification for repeat dose toxicity (including carcinogenicity and reproductive toxicity) and for mutagenicity;
- Concentration limits and calculation methods for classification where no product data are available;
- Environmental classification (NB this is new for all preparations, not just pesticides);
- A new symbol (tree and fish) for environmental labelling;
- New ‘risk and safety’ phrases for repeat dose toxicity, mutagenicity and environmental effects;
- More stringent criteria for allocating safety phrases, including those phrases for protective clothing;
- A new phrase for all pesticide products - ‘To avoid risks to man and the environment, comply with the instructions for use’.
Approval Holders’ Responsibilities
The Pesticides Safety Directorate (PSD) intends that the responsibility for reclassification and labelling of pesticide products should rest with approval holders (in line with suppliers’ responsibilities for general preparations under the CHIP Regulations).
Brief details of the revised classification and labelling for existing approved products (2 or 3 pages only), or nil returns if appropriate, should be notified to PSD’s Approvals Support Group by 31 October 2003.
PSD’s current intentions are to undertake some checking at this stage, and/or at re-registration following review. We will provide further information on these proposals in due course.
By 31 October 2003 and subsequently, applications submitted to PSD for new products should include classification and labelling details under Directive 99/45/EC.
We appreciate that parallel approval holders may not have access to sufficient information to enable them to reclassify and label their products. We will provide further advice to this group of approval holders as to the appropriate action they should take.
Amateur Products and Protective Clothing
Under the Government’s current policy, approval may not be granted for amateur products where protective clothing is required for safe use. This policy arises from a decision made by Ministers, following consideration of the issue by the Advisory Committee on Pesticides in 1997. In light of the CHIP 3 labelling requirements for protective clothing, PSD will put a submission to Ministers asking them to review the existing policy with respect to amateur products and protective clothing. Further information on this issue will be provided in due course.
Directive 91/414/EEC, Annexes IV and V
The European Commission (EC) Commission has been considering the ‘risk and safety’ phrases that are currently used for plant protection products in all member states. The Commission aims to provide consolidated lists of these phrases in Annexes IV and V of Directive 91/414/EEC towards the end of this year. In the interim period, we appreciate that approval holders may have some questions about particular phrases e.g. those describing protective clothing requirements or environmental labelling. PSD will also be providing further guidance on these areas and label layout in due course.
Contact Information
If there any queries concerning the contents of this letter, please do not hesitate to contact Debbie Hussey or Francis Daly, Approvals Secretariat Branch by e-mail on debbie.hussey@hse.gsi.gov.uk or francis.daly@hse.gsi.gov.uk, by phone on 01904 455769 or 01904 455824, by fax on 01904 455733 or 01904 455722, or in writing.
