by James Calder
The EU’s R.E.A.C.H (Registration, Evaluation, Authorization and Restriction of Chemicals) regulation ensures all European manufacturers and importers must identify and manage the risks that chemical substances manufactured and marketed may pose to human health and to the environment. The first of three deadlines closed on Dec. 1, 2010. Many companies hoped to breathe a great sigh of relief; however, most organizations were not well-prepared for the deadline of notification under the Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation. The Notification mandated a separate submission of data for all that will be registered under R.E.A.C.H. and any other hazardous substance irrespective of tonnage. Meeting these tight deadlines has many companies looking for a moment of repose. The reality is they must continue at the same pace.
Funding and Effort
The European Chemical Agency (ECHA) has accepted almost 25,000 dossiers for processing leading up to the December deadline. This number is mostly represented by large companies (86 percent) registering substances that are manufactured or imported in quantities greater than 1,000 tonners (90 percent). If one were to take a general calculation of the registration fees payable to the ECHA based on the submitted registrations, this could amount to approximately €500 million. There are other non-agency fees that arise from licensing Letters of Access to share study data and the less tangible costs of internal and external human resource funding.
The sheer scope of effort and funding makes it absolutely essential that every decision taken during the R.E.A.C.H. program is reviewed and augmented to support potential enforcement activity. The EU’s first enforcement activity saw more than 1,500 enforcement actions performed by Member State authorities. It can only be expected that enforcement will grow as the agencies themselves will have matured and expanded for tighter controls within the chemical industry. This reason alone makes it imperative to document and substantiate the decisions leading to product definition, registration, safety communication and any other immediate responsibilities to R.E.A.C.H.
Are Your Volumes Covered?
The cosmetic industry, usually falling within the definition of brand owners and/or final formulators, has experienced a heavy reliance on suppliers pertaining to R.E.A.C.H. registration. This issue arises in many cases. Why? Certain ingredients are extremely proprietary and typically not disclosed to the formulator. To cover the formulator’s obligations, the formulator will need to ensure substances that require registration within their supply chain are properly registered and the formulator’s tonnages have been covered in the registration.
This approach seems simple from a theoretical standpoint, but experience demonstrates that this can be much more time and labor intensive—especially in complex supply chains. A primary example would be the non-EU substance manufacturer (Company A) that has appointed an Only Representative to cover their sales to a non-EU formulator (Company B) who then sells their formulation to an EU entity (Company C) that will further formulate into the final product for distribution within the EU That sentence alone is complicated enough but nothing in comparison to ensuring the EU entity’s tonnages is covered by the appointment of the Only Representative.
To do this, Company A must notify Company C in writing of the appointment of the Only Representative with confirmation that the substance tonnage purchased by Company C will be covered under the appointment. Company A must then notify Company B of this appointment and ensure Company B reports to Company A the total volume of the substance (contained in the now formulation) sold to Company C. Company B will then have to ensure that substances in the formulation not covered by Company C have a similar program in place within their respective supply chains to ensure the whole formulation is covered.
Downstream users, manufacturers/formulators and importers will have significant work ahead of them if they hope to manage their supply chain without with the potential of facing fines, stop shipment/manufacture, or even further civil action. But how do companies manage their supply chain operations to ensure this does not happen? Companies must educate their staff responsible for procurement, sales, development and—most importantly—regulatory compliance. Beyond the human resource aspect, companies must ensure they have updated PLM systems to generate R.E.A.C.H. relevant data.
The next enforcement project coordinated by the EU Member State enforcement agencies will begin April 2011 and is known as REACH-EN-FORCE 2 (the first is still in operation). This second project will target formulators of mixtures. Although the project is still being developed, it is likely to focus on downstream user obligations relating to compliance with R.E.A.C.H. safety data sheet requirements and use-related duties.
The cosmetic industry falls heavily within the scope of the intended target; therefore, performing the necessary checks and balances within the supply chain will be the difference from market loss and growth. To do this, the following must be answered:
- Are all substances used in your product pre-registered or registered?
- If so, do you have supporting evidence to show the pre-registration or registration covers your volume?
- If the substances are registered, is the use of the substance covered under the registration dossier?
- Are there any SVHCs in the packaging or containers in your product portfolio?
- Have you access to updated Safety Data Sheets (SDS) in the language(s) of the EU Member State?
- If you have substances that need to be registered in 2013, have you commenced activity to generate data for their successful registration?
All these activities should not take away from the incredible lengths taken by industry, governments, trade associations and other key players within the implementation of R.E.A.C.H. Rather they should be used as the springboard for strengthening the current program. Invest in your compliance program so you can react in a manner that saves you money in the end. A perfect example would be an instance where Intertek's Regulatory Group in the EU reduced a client's letter of access cost from €300,000 to €80,000. This was only possible with thorough understanding of the science behind R.E.A.C.H. in addition to the business practices surrounding the implementation.
James Calder is the manager of regulatory services at Intertek. For more information on R.E.A.C.H. regulations, contact Calder at [email protected].