An example of bad EU regulation

A nasty surprise hidden in the new Classification and Labeling Regulation

On 20 January 2009, a hidden change in the EU Regulations was introduced.  It triggers thousands of cleaning products to become classified as dangerous chemical products and causes hundreds of industrial facilities in the EU to become major accident hazard facilities.  As such nothing new, except that it was triggered by a hidden change in the text, and that the competent EU officials seem to be trying to hide their mistake.

At stake is the Regulation EC/1272/2008 (the CLP Regulation), which implement the United Nations Globally Harmonised System for Classification and Labeling of Chemicals in the European Union and enters into force on 20 January 2009. The CLP Regulation will overhaul the present system of classification and labeling of substances in 2010. The new classification and labeling system for mixtures and preparations begins in 2015.

While the major reforms do not begin until 2010, immediate consequences for companies are already appearing. In order to provide operators during the transition period with only one text to refer to for the harmonized classification of chemical substances, recital 53 to the CLP Regulation states that “all existing harmonised classifications should also be placed unchanged in an annex to this Regulation”. Despite the clear intention to transfer the harmonized classifications unchanged, some changes were made in transferring Annex I of the Dangerous Substances Directive 67/548/EEC to Annex VI Part III to the CLP Regulation,.

Most significantly, harmonized classifications no longer include the generic concentration limits. Generic concentration limits (25%, 2.5% and 0.25%) were introduced by Directive 1999/45/EC to define the classification of the preparation based on the quantity of the component substances and their environmental classification. Also, in the transfer to the CLP Regulation, the specific concentration limits that corresponded to the generic ones were cancelled.

There has been little explanation of these changes. The changes, and their consequences, are not mentioned in  the Regulation, the explanatory documents or the websites of the European Commission. Moreover the changes are not mentioned in the interim report from the Technical Working Group on Seveso and GHS, which was established in order to review the potential impact of GHS classification rules in a Seveso context.

Only the Q&A document issued by the European Chemicals Agency (ECHA) in May 2009 makes  mention of the change. The ECHA states that the primary idea behind inclusion of the generic concentration limits in Annex I to Directive 67/548/EEC was to provide classifiers with an “all in one” table.  As the CLP Regulation contains the classifications (in Table 3.1 of Annex VI) in accordance with the CLP criteria which no longer provide for any generic concentration limits, it was decided to delete them from Table 3.2 (classifications in accordance with 67/548/EEC) as well, to avoid confusion and improve readability between the tables. Thus, according to ECHA, the elimination of generic concentration limits was only a cleaning up exercise and no consequence is mentioned.

Despite the silence of the European Commission on the omission of the generic concentration limits, the changes do have important consequences. The modification affects many substances, but it is not immediately obvious how many nor which ones are affected.  In order to seek clarification, Enhesa experts called the competent EU official in charge of classification, but the surprising response was that the change was known to everyone and that one could contact the industry associations to figure it out.  We used to get this type of responses several decades ago, when the government regarded regulations as top secret.  This attitude undermines the ideas of better regulation and open access to information – two concepts that the EU has attempted to defend.

Taking the official on her word, we called her colleague next door in charge of major-accident hazard facilities, and got the surprising answer he was not aware of any change.  The EU adopts the Regulation, and the Member States have to enforce it.  So we called the competent enforcement agencies in a dozen member states and most of them were not aware of any change.  Only three Member States seem to have understood what has happened and have attempted to clarify the situation.  But surprise again, their analysis differs greatly – 222 chemicals are affected according to the Italian Ministry of Health; 98 have been identified by the Hungarian authorities; while the French authorities have identified 86 affected chemicals.  The Italian and French authorities have issued circulars on the issue to help clarify the situation.

For most of these substances, the changes have no consequences. But about 20 to 40 substances are affected in terms of classification of mixtures that contain them. Substances that are assigned the risk phrase R50 or R50/53 (very toxic to the aquatic environment) are, in the absence of a specific limit, subject to Directive 2006/8/EC. According to this Directive, for these substances the specific limit to be adopted has to be identified in function of the effective value of CL50 or EC50. This way, the 25% limit may remain the same, but it can also be divided by 10 or 100 and thus become 2.5% or 0.25% through the identification of an M-factor. An M-factor is a multiplying factor. The concept of M-factors has been established to give an increased weight to substances that are very toxic for the aquatic environment when classifying mixtures containing these substances.

Particularly striking is the classification of Sodium hypochlorite, commonly used as bleach. The specific concentration limit has been deleted in the new CLP Regulation and replaced by a general provision with the M-factor. Where there is no harmonised M-factor listed in Annex VI to CLP for a specific substance, manufacturers, importers and downstream users should set an M-factor themselves when classifying substances for acute aquatic toxicity category 1 or chronic aquatic toxicity category 1. Tests reveal an M-factor of 10 should be assigned to sodium hypochlorite which means that solutions of 2.5% active chlorine will need to be classified as “Dangerous to the Environment” (N; R50).

This means that there are immediate consequences for some companies. From 20 January 2009, when the CLP Regulation entered into force, mixtures containing substances for which the generic or specific concentration value was cancelled had to be reclassified and relabeled according to Annex VI Table 3.2 of the CLP Regulation. There is no grace or transition period included in the CLP Regulation, probably because when this “clean-up” was carried out, these consequences were not foreseen and communicated to the enforcement agencies in the EU member states. Companies placing mixtures on the market that should be labeled differently, as a consequence of the changed concentration limits,  must immediately change the labels of all mixtures placed on the market.  Failure to do this exposes the company to substantial liability.

In addition, the introduced change affects the classification of installations under Directive 96/82/EC on the control of major-accident hazards involving dangerous substances (the Seveso II Directive). Concerned substances classified as dangerous for the environment and assigned R-phrase R50 (very toxic to aquatic organisms) contained in certain concentrations in mixtures manufactured or used by companies could now, due to stricter concentration limits, be caught up by the Seveso II Directive.  A facility will fall under the Seveso II Directive if dangerous substances exceeding the thresholds as listed in Annex I Part 1 or 2 to Directive 96/82/EC are present on site. For substances classified as dangerous for the environment and assigned R-phrase R50 (very toxic to aquatic organisms), the qualifying quantities to become a Seveso II site are 100 tons (for facilities subject to Article 6 and 7 of Directive 96/82/EC) or 200 tons (for facilities falling under Article 9 of Directive 96/82/EC).

Due to this accident in the transposition of the harmonized classification from Annex I of Directive 67/548/EEC, many industrial facilities are at risk of operating illegally without the proper permit.  Enhesa recommends that facilities check their chemical inventory against Annex VI Part III of the CLP Regulation. If there are consequences in terms of the facility’s Seveso classification, the facility should check the transition period granted by the transposition of the Seveso II Directive. Depending on the Member State concerned, this transition period will often be 6 months (20 July 2009) or 12 months (20 January 2010).

Neither the intent of the regulators or the final outcome is the problem.  However, the lack of communication on the issue and the lack of transition periods are deplorable, and put both industrial operators and enforcement agencies in a difficult position.  To be continued.

Vito Buonsante & Thierry Dumortier

For more information on Enhesa and how we can help you comply with international EHS regulations, visit out website at


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