May 2017 Edition

ChemRegs Newsletter – May 2017

CLP – 1 June 2017

June 2015 marked the deadline for suppliers and manufacturers of chemical products to stop using the old CHIP regulations to determine the hazardous categories of their products, and to start using EU Regulation 1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures (CLP).

CHIP was an abbreviation for the Chemicals (Hazard Information and Packaging for Supply) Regulations. CHIP implemented the now revoked European Dangerous Substances Directive (No. 67/548/EEC) and Dangerous Preparations Directive (No. 1999/45/EC).

This change in chemical classification methodology from CHIP to CLP also had implications for COMAH.

COMAH implements Seveso III (the EU Directive on control of major accident hazards), and applies to any business where hazardous substances are present on-site above certain threshold quantities or could be generated in the event of an accident. The re-classification of chemicals to align them with CLP lead to changes in hazard category that changed COMAH liability. Some lower tier COMAH sites become upper tier and some sites were brought into COMAH for the first time.

In addition to COMAH, the new CLP methodology had to be used to classify hazardous waste. It also had an affect on COSHH (Control of Substances Hazardous to Health Regulations 2002). The more severe the classification under CLP, the more likely the substance is to attract additional control measures under COSHH.

However, in June 2015 the new CLP regulations were going to cause issues for products that were classified under the old CHIP regulations and were already in the supply chain i.e. ‘on the shelf’.

To mitigate this, a transitional or grace period was given to use up stock on the shelf that were classified under the CHIP methodology and had the old CHIP symbols on them.

It is this grace period that is coming to an end on the 1st June 2017.

All chemical products that have the CHIP symbols on them must be withdrawn from sale by the 1st June 2017. Further, any Safety Data Sheet that has CHIP classifications or labelling elements in it must now be revised to conform to Annex II of REACH as amended by Regulation (EU) 2015/830.

Old stock can either be disposed of, (however you must ensure they are consigned as hazardous waste, ironically using the new CLP methodology), or re-classified using CLP and the labels changed to the CLP format.

CLP is based on the United Nations’ Globally Harmonised System on the classification and labelling of chemicals (GHS) and implements the GHS throughout the member states of the European Union.

GHS is a putative worldwide system for classifying and communicating the hazardous properties of chemicals and sits alongside the UN ‘Transport of Dangerous Goods’ system.

The United Nations’ GHS is not a formal treaty, but instead is a non-legally binding international agreement. Therefore, countries (or trading blocks) must create local or national legislation to implement the GHS.

GHS aims to ensure that information on the hazardous properties of chemicals is available throughout the world in order to enhance the protection of human health and the environment during the handling, transport and use of chemicals.

GHS also provides the basis for harmonising regulations on chemicals at national, regional and worldwide level. This is important for facilitating trade. At a more basic level, GHS also aims to provide a structure for countries that do not yet have a classification and labelling system.

The word harmonising is important, as the UN GHS is still in the process of being implemented. Not all countries are signed up to it or implement it fully.

Each country can decide to just implement parts of the GHS. This is called the ‘building block’ approach. Building blocks are hazard categories, which each country can adopt or not.

For example, the building block of hazard category acute toxicity.

Acute toxicity refers to those adverse effects occurring following oral or dermal administration of a single dose of a substance, or multiple doses given within 24 hours, or by inhalation with an inhalation exposure of 4 hours. These are expressed in numerical criteria as either LD50 (oral and dermal) or LC50 (inhalation).

LD50 is the “Lethal Dose” of material that will cause death in 50% of the tested animals within 24 hours of exposure, whereas LC50 is the “Lethal Concentration” of the chemical in air that will cause death in 50% of the tested animals in the exposure duration of 4 hours.

Substances are assigned to one of five acute toxicity categories, with Category 1 as the highest acute toxicity category. Therefore, even small amounts in a product will make it toxic (e.g. 5mg/kg by the oral route and 50 mg/kg by the dermal route).

Substances in Category 5 have an oral and dermal LD50 in the range of 2,000 – 5,000 mg/kg; therefore it will take a large amount in a product to make it toxic.

The EU through CLP does not recognise Category 5 acute toxicity. So if you have a chemical product that is classified under the GHS system as acute toxicity 5 in the EU it is not classified as hazardous and you would not need to put any hazard pictograms and warnings on the label of the product. However, if you were to put the same product on the market in Brazil, Canada, China, or Mexico, then you would need to classify the product as hazardous and put the hazard and precautionary statements on the label, and supply a safety data sheet for the product.

Another variation is differences in the classification of mixtures using cut-off values/concentration limits of the ingredients of a mixture to trigger classification of the mixture in a particular hazard category. This is known as the ‘compromise classification scheme’ and is the result of the inability to achieve consensus of a cut-off value by the experts in charge of the GHS. There are two concentration limits and every competent authority must adopt at least the higher concentration limit as a trigger for mixture classification, but the lower limit may also be adopted.

The USA Occupational Safety and Health Administration (OSHA) via HCS/HazCom 2012 has adopted the lower limits in the compromise classification scheme, while Europe via CLP has adopted the higher limits, resulting in products that can be potentially be classified and labelled differently in the country of manufacture and the country of sale.

This affects the following hazard categories:

Carcinogen Category 2: the lower limit for classification of the mixture as Carcinogen Cat 2 is ≥0.1% of a Cat 2 carcinogen ingredient and the upper limit is ≥1%.

Reproductive toxin: the lower limit is ≥0.1% of a Cat 1A, 1B, or Cat 2 reproductive toxicant and the upper limit is ≥0.3% for 1A/1B or ≥3% for Cat 2.

STOT SE: the lower limit is ≥1% of a Cat 1 or 2 STOT SE component and the upper limit is the lower limit is ≥10% for Cat 1 or 2. The guideline value is ≥20% for Cat 3.

STOT RE: the lower limit is ≥1% of a Cat 1 or 2 STOT RE component and the upper limit is the lower limit is ≥10% for Cat 1 or 2.

The UN GHS experts believe that the number of affected mixtures will be small; the differences will be limited to label warnings, and the situation will evolve over time to a more harmonized approach.

Yet another variation is that some countries have limited the number of precautionary statements on the label to make it more readable.

The EU and Malaysia make it mandatory that no more than 6 precautionary statements shall appear on the label unless they are necessary to reflect the nature and the severity of the hazards. This is currently advisory in Korea and Australia. Whereas the USA, Canada and Japan require all of the appropriate precautionary statements to appear on the label. This can mean that a product with multiple hazards can have 20-30 precautionary statements on a label!!

In summary, old CHIP products and labels must be withdrawn from sale at midnight tonight (31/5/2017) and you can only have products with the new CLP labels on your shelves for sale.

The EU will have then fully adopted CLP, which is part of GHS building blocks methodology. Unfortunately, harmonisation is still to be achieved as not all countries have adopted all the building blocks and there are still variations in classification and labelling.

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