IMPLEMENTATION OF THE CLP REGULATION SUMMARY FOR THE FERTILISER INDUSTRY

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1 Background The EU s Classification, Labelling and Packaging (CLP) Regulation (EC) 1272/2008 was enacted to protect workers, consumers and the environment from the impacts of hazardous chemicals. CLP incorporates the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals criteria into Community Law and compliments the REACH Regulation. Some materials have been re-classified due to the REACH process which has led them to fall under the CLP Regulation (e.g. AN). The CLP Regulation, which is being phased in over 5 years, requires manufacturers, importers, and downstream users to classify, label, and package substances and mixtures in accordance with the CLP Regulation before placing them on the market within the EU. CLP Objectives The purpose of CLP is to: Provide a comprehensible system of hazard communication across the EU. Provide a recognized framework for those countries without an existing system. Reduce the need for testing and evaluation of chemicals. Facilitate international trade in chemicals. CLP Deadlines There are *timescales for the fertiliser industry to classify and label substances and mixtures in line with CLP rules. CLP label for substances 1st Dec 2010 (1st December 2012 for product already packed) CLP label for mixtures 1st June 2015 (where the classification of the substances used as ingredients has not changed (1st June 2017 for product already packed) New Safety Data Sheets for substances, new mixtures or mixtures where one of the ingredients has been reclassified - 1st Dec

2 Safety Data Sheets for existing mixtures that have been issued at least once before 1 st Dec 2010 are ok until 1 st Dec 2012 *After the June 2015 deadline, the CLP Regulation will repeal the European Union s Dangerous Substances Directive (67/548/ECC) and the Dangerous Preparations Directive (1999/45/EC). Classification CLP places a general obligation on all suppliers in the fertiliser supply chain to classify, label and package substances according to CLP requirements before placing them on the market. Materials should be referred to as either a substance or a mixture. See Glossary for the definition of a substance or mixture. Preparation is sometimes used to describe mixtures but in CLP and REACH they are synonymous. Classification involves four basic steps: Gather all available information Examine information to ensure it is adequate and reliable Evaluate available information against classification criteria Decide on appropriate classification Downstream users must not chemical modify a substance or any substances present in a mixture if they do they are manufacturing and must register under REACH before the material is placed on the market. If downstream users change the composition of a substance or mixture, they should classify in line with CLP Title II before placing it on the market. If any of the constituents of a mixture have been re-classified as being hazardous in the REACH Chemical Safety Reports, then suppliers have an obligation to re-label as soon as reasonably practicable, and reissue updated Safety Data Sheets (see below). Classification of AN Depending on whether it includes more than one substance, high-nitrogen AN is classified as either a substance or a mixture. Ammonium nitrate containing 34.5% N from AN is regarded as a substance. Ammonium nitrate containing 33.5% N from AN is regarded as a mixture. Under REACH, AN has been classified as both an oxidising agent and an eye irritant. Under CLP, the packaging must therefore display the necessary hazard warnings and 2

3 pictograms (see below). A new safety data sheet will therefore be required from 1st December Under CLP, mixtures containing >10% of a substance classified as an Eye Irritant (AN) are also classified as Eye Irritants (See Tables and of the CLP Regulation). Changes to labelling of these mixtures needs to be mad within a reasonable time and without undue delay after 1 st December. Existing stock on 1 st December does not need to be relabelled. Notification Manufacturers and importers are required to notify a substance to the Classification & Labelling (C&L) Inventory established at ECHA in cases where they are placing the substance on the market unless it has been previously notified under REACH and they either: Manufacture the substance and it is subject to registration under the REACH Regulation; or Import the substance and it is subject to registration under the REACH Regulation; or Manufacture or import the substance and it is classified as hazardous, irrespective of the quantity; or Import a mixture which contains the substance that is classified as hazardous and is present above the relevant concentration limit, which results in the classification of the mixture as hazardous according to the CLP Regulation; or Import an article containing substances which are subject to registration under Article 7 of the REACH Regulation. In the event that new information leads to a revision of the classification and labelling of the material or there is new hazard information, the relevant registration document must be updated as soon as possible. Notification to Classification & Labelling Inventory (European Chemicals Agency - ECHA) must be done by 1 st December (There is a grace period of one month up to 3 rd January 2011).Thereafter you must notify the classification and labelling of a substance within one month of placing it on the market. Labelling and Packaging Under CLP, suppliers must replace the Dangerous Substance Directive (DSD) and Dangerous Preparations Directive (DSP) risk phrases, safety phrases and symbols with the equivalent CLP hazard statements, precautionary statements and pictograms. The terms used in CLP are similar to those used in DSD and DSP but are not identical. 3

4 It is important to note that labelling requirements can arise from three different regulations: CLP transport related regulations, such as ADR in the case of classified products fertiliser regulations (which require declaration relating to the nutrients). Provision has been made in CLP to avoid duplication of pictograms to be displayed on the labels, (see below). Under CLP, labelling should include (where product is classified): Name, address and telephone number of the supplier Emergency telephone number Nominal quantity of substance or mixture Product identifier (EC and CAS number) Hazard pictograms Signal words e.g. Warning Hazard statements (see Annex IV of CLP) Appropriate precautionary statements (see Annex IV of CLP) Supplementary information where appropriate Labels should be firmly affixed to one or more surfaces of the packaging. Note: for ADR classified products the Danger Labels need to be on two opposite sides of the pack. Labels must be written in the official language of the Member State where it is to be placed on the market. Distributors must ensure that substances and mixtures are labelled and packaged in accordance with CLP Titles III and IV before placing them on the market. Pictograms Pictograms depicting the specific hazard class(es) should be displayed on the label. Pictograms should cover at least one fifteenth of the surface area of the label, should be in the shape of a diamond and should have a black symbol on a white background with a red border. Where a pictogram is required under ADR, the equivalent CLP pictogram need not be displayed as well, e.g. prilled AN carries the yellow diamond UN oxidising agent symbol, and therefore does not need to also show a CLP red/white diamond oxidising agent symbol. 4

5 Example Pictogram for Eye Irritant Safety Data Sheets The requirements for Safety Data Sheets (SDS) are laid out in Annex II of REACH. Companies must supply SDS s for all substances or mixtures classified as hazardous under the CLP Regulation. An SDS is also required for a mixture not classified as hazardous, but contains greater than 1% of a substance posing human health or environmental risks (See REACH Regulation Article 31(3)). In this regard, micronutrients must be considered and especially those containing compounds of boron. Significantly more information will be required on SDSs under REACH than has previously been required. The length of the SDSs must be indicated (e.g. page 1 of 12) Exposure Scenarios Extended Safety Data Sheets (esds) will contain Exposure Scenarios for each registered use. 5

6 Exposure Scenarios must be prepared and annexed to SDSs. They should cover all identified uses and should include conditions and risk management measures that describe how the substance or mixture is manufactured or used during its life cycle and how downstream users should control exposures of humans and the environment. They should communicate operational conditions of use and risk management conditions through the supply chain. These will have been prepared by the company in the supply chain responsible for the REACH registration. Record Keeping CLP and REACH require information to be kept and made available for inspection for at least 10 years after a substance or mixture was last supplied. This could be information related to classification, labelling or provision of SDSs. Enforcement The CLP Regulation will be enforced in the UK by the Health and Safety Executive. Further Guidance Introductory and Technical Guidance on the CLP Regulation can be found on the ECHA website HSE have announced that there are no plans to provide any guidance on CLP at UK level. However, the CLP Regulation requires member states to establish a national Helpdesk to assist chemical suppliers. This obligation is fulfilled through a joint REACH/CLP Helpdesk. Contact details are: REACH and CLP UK Competent Authority Helpdesk, Health and Safety Executive 2.3 Redgrave Court, Merton Road L20 7HS Bootle Merseyside UKREACHCA@hse.gsi.gov.uk CLP website The HSE have created some advice/guidance on the implementation of REACH. See FREQUENTLY ASKED QUESTIONS Labelling and Packaging Q. We carry a stock of packaging for a range of bagged products which will be expensive to adapt or replace. Will we be able to use up this stock for packing 6

7 substances after 1 December 2010? Or must we use CLP designed packaging immediately from that date? A. To the letter of the law it is 1 st December, in reality, as soon as reasonably practicable but the message from HSE is that this should not be abused. SDS Q. Safety Data Sheets are available on our website. Are we obliged to proactively inform our customers by sending SDSs of all our products (hard copy or ) or is drawing attention to our website sufficient? A. You need to demonstrate proactively that you have informed your customers drawing attention to the internet is not sufficient. Q. Do we require formal written acknowledgement from the farmer that they have read and understood the advice or have we fulfilled responsibility by proactively drawing attention to the advice by sending it to them? A. No, demonstrating that you have proactively informed farmers by sending them the SDS is adequate. Q. Do I need to provide an SDS with every delivery? A No. Only once, unless the classification of the particular substance or mixture changes, or there is a significant change to the SDS (e.g. company details, formulation change). Glossary Manufacturer Any natural or legal person established within the Community who manufactures a substance within the Community. Mixture/Preparation Mixture or solution composed of two or more substances. Substance A chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition. Importer Any natural or legal person established within the Community who is responsible for import 7

8 Supplier of a substance or a preparation Means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a preparation, or a preparation Safety data sheet (SDS) The safety data sheet is the main tool used in industry for communicating information on the hazard of dangerous substances and preparations through the supply chain. Annex II of REACH is based on the Annex to the safety data sheet Directive (91/155/EEC) and explains what information should be included under each of the 16 safety data sheet headings. Distributor Means any natural or legal person established within the Community, including a retailer, who only stores and places on the market a substance, on its own or in a preparation, for third parties References 1. Regulation No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on Classification, Labelling and Packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/ Regulation No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). 8

9 Action Notification to C&L Inventory Classification Manufacturer of substance Blender Importer Third Party Store Keeper Merchant (Distributor) End User Y N Y* N N N Y Y Y* N N N Labelling of Y Y Y** N Y** N Packaging Provision of Y Y Y N Y N SDS Receipt of SDS Y Y Y Y Y Y * of material from outside the EU ** Responsible for own label and packaging DISCLAIMER: The information given in this Summary is provided in good faith. No responsibility or liability for any loss or damage is accepted by AIC, its committee members, staff or consultants arising from use of the information. Readers are advised to refer to the Classification, Labelling and Packaging Regulation (EC) No 1272/2008 and relevant Guidance on the ECHA website. AIC November