Forgotten Regulation - Walking in the footsteps of Reach the 2008 EU Classification, Labeling and Packaging (CLP) Regulation (Regulation (EC) 1272/2008) has received less attention than it deserves from authorities, supply chains and senior management, who are still trying to cope with the massive resource and business implications of Reach. Andrew Fasey explains why despite the pain, businesses stand to gain from putting in place comprehensive compliance strategies for the EU regulation on classification, labeling and packaging of substances and mixtures (CLP).

The Reach and CLP work hand-in-hand yet, owing to its origins, CLP has an international dimension that is both important and fascinating and which promises a vision - one day - of a world far less at risk from the hazards of chemicals than today. However, the agents of this change are expected to be companies who may have a long way to go to understand the compliance challenges posed by CLP and its underpinning regime.

The Background

The CLP Regulation entered into force on Jan. 20, 2009, following its publication on Dec. 31, 2008 in the Official Journal of the European Communities. Although it has not attracted the political furor that Reach did, in many ways it will have as important repercussions for companies. Its requirements require rapid, coordinated, effective and efficient action to ensure compliance. Planning to meet these requirements effectively and efficiently, preferably in co-ordination with the requirements of Reach, will give many advantages to the companies concerned.

The Deadlines

One key difference from Reach is the very obvious international dimension. CLP implements in the EU the Globally Harmonized System for the classification and labelling of chemicals (GHS). The GHS will continue to be implemented in most countries across the globe over the coming years.

Time and effort spent implementing CLP in the EU should therefore confer additional benefits on companies in improving their access to non-EU markets as well. It is therefore important for such companies to plan their implementation activities from a global perspective. Unfortunately, the lead times for many posed specifically by the CLP regulation will be short. The three most pressing and important deadlines under CLP are:

• Dec. 1, 2010 - the deadline for the (re)classification of substances in accordance with CLP.
• Jan. 3, 2011 (in practice Dec. 24, 2010) - first deadline for the notification to the classification and labeling inventory of substances placed on the market on Dec. 1, 2010. (notifications are due 30 days after placing on the market starting from Dec. 1, 2010.
• June 1, 2015 - deadline for the (re)classification of mixtures in accordance with CLP.

Safety Data Sheets

It should not be forgotten that the new requirements for safety data sheets (SDS), closely linked to CLP of course, start from Dec. 1, 2010 as well. Annex II of Reach sets out the requirements for SDS. This Annex was amended through the Commission Regulation No. 453/2010 that was published on May 31.

This amendment makes very significant changes to the SDS provisions by introducing a new version of Annex II that must essentially be complied with from Dec. 1 for substances and a further new version that will be applicable from June 1, 2015 additionally for mixtures (although this basically only removes a requirement to continue to show classifications as per the "old" system under the Dangerous Substances Directive and Dangerous Preparations Directive). It should be noted that the "new" SDS rules for mixtures can also be applied from Dec. 1, as long as classifications under DSD/DPD are shown as well as those arising from application of CLP.

CLP - The Bottom Line Hits

CLP will impose a variety of costs on companies depending on their business, its scale and location, and on the position in the supply chain. The following activities will be required by most companies and will need to be resourced:

• Inventory preparation and updating
• Systematic reviews of requirements from, and related to, CLP
• IT systems to manage CLP
• Reclassifying, relabeling and repackaging products
• Updating SDS
• Training (e.g. staff implementing CLP and workers using classification and labeling information)
• Following CLP and GHS developments (the GHS is updated every two years and CLP will need to follow these changes. The EU will also introduce other changes such as adding substances to the list of those that are harmonized in the EU).
• Testing for physicochemical properties of substances and mixtures if this information does not already exist (NB. this is a requirement now but it is often overlooked).

Piecemeal CLP Compliance - The Risks

In a short article, it is not possible to tell companies everything they should do to ensure effective and efficient compliance. It is sadly far easier to inform them of what might happen if they fail to do a good job:

• Non-compliance could lead to fines, imprisonment, loss of reputation and loss of markets in the UK, EU and globally. The introduction of CLP will lead to increased enforcement activity (coupled with Reach) and the publication of the classification inventory will provide far greater transparency over the activities and regulatory compliance of companies. Already the EU member states have agreed a second coordinated enforcement project starting early in 2011.
• If companies are not "joined-up" in their approach, there is the risk of reinventing the wheel in each country as GHS is implemented. This is a waste of resources and could potentially lead to different decisions being taken in different markets for the same product.
• The failure to have effective systems in place could mean that accurate implementation measures are not in place, changes are not tracked and acted upon and the impact on downstream legislation missed. A failure to implement one piece of legislation implies that other failures in related legislation will subsequently be discovered with potentially serious implications for the company.

What Your Company Should Be Doing

To reduce the risks from piecemeal or non-compliance, companies should be doing some or all of the following:

• Joined up working across organizations is essential, the following parts of the business, for example, should work together:
  - National
  - EU
  - Global
  - REACH team
  - Regulatory specialists
  - Environment, health and safety (EHS)
  - Legal
  - Procurement
  - Sales
  - R&D
  - Others
• Resources are needed to ensure effective and efficient implementation; what, where and when. It should be recognized that CLP and GHS will change and evolve over time - work on CLP should not be considered to be a one-off exercise.
• Training will be needed to help ensure that those workers applying CLP and using classification, labeling and packaging information understand the new system.
• Consider preparing a vulnerability assessment to see where CLP (and GHS) may have most impact on your business.
• Up-to-date inventories are needed of all products coming into, through and out of the company to ensure that CLP is fully addressed. Remember there is no tonnage threshold for the classification and labeling inventory, the scope of CLP is different to that of Reach and exemptions are relatively few. The inventory should be a living document as products in the supply chain and associated quantities and corresponding duties will change over time.

CLP and GHS may have a greater impact on companies globally than Reach. They should not therefore be seen as the poor relation of Reach. Careful consideration needs to be given to the steps needed within a business to ensure effective and efficient implementation to minimise the downsides and maximise the business benefits.

Infobox
Andrew Fasey and Mark Blainey are the authors of a new Chemical Watch report - Managing CLP Compliance: The Essentials for Business - which offers an easy-to-read, step-by-step guide.
As well as dissecting the EU CLP Regulation to show how it works, the authors explain the implications for companies, with messages aimed at senior management to explain why they should release resources to maximize the benefits from compliance. The report also presents advice written specifically for the report by the European Chemicals Agency plus comprehensive references and corporate case-studies looking at existing compliance strategies, making it a truly practical tool.
A 20% discount is available to CHEManager Europe readers (discounted price €197). Contact lorna.m@chemicalwatch.com stating "CHEManager offer." Also see contents summary at www.chemicalwatch.com/clp

Andrew Fasey (andrew.fasey@ptkltd.com) is founder of the consultancy Protection Through Knowledge (PTK) Ltd and also provides regulatory services through the REACH Centre based at Lancaster University in the UK. Andrew was part of the team in the European Commission that drafted the Commission's proposal for REACH and also a member of the Inter-Organizational programme for the sound Management of Chemicals (IOMC) Drafting Group, representing the EU and UK, which prepared the first version of the Globally Harmonised System for the classification and labelling of chemicals (GHS) and also represented the European Commission and the UK at meetings of the UN SCEGHS (United Nations Sub-Committee of Experts on GHS).