Industry has much to consider with Reach
Over the next 10 years around 30,000 substances will be subject to the new Registration, Evaluation and Authorisation of Chemicals (Reach) legislation, which comes into force in Europe in June 2007.
This is one of the most complex legislative instruments to affect industry and it will have a significant impact across manufacturing industry, including packaging. It is impossible to generalise about the impact of Reach as the devil is very much in the detail, but packaging firms need to consider Reach’s relevance to their business and determine where further evaluation of the chemicals used is required.
Reach does present risks but may also stimulate change, opportunity and, in some cases, a different way of doing business.
Direct impact
The direct impacts may not be as significant as those for chemical manufacturers but packaging organisations that have processes close to basic chemical production, such as producing monomers, will be affected and have most to do. Firms producing polymers containing free monomers or additives may also be affected.
If an organisation has to put substances through Reach, it will have to pre-register interest in that substance; register the substance, either as a standalone entity or as part of a consortium; and potentially subject the substance to more detailed evaluation – this may lead to authorisation.
Reach will have two direct implications – cost and risk. If a firm has to register substances this will lead to both direct costs – mainly related to registration, evaluation and testing – and indirect costs – arising from raw material price rises, revalidation, management time and lost opportunity.
Packaging firms should not overlook the fact that the Reach process itself may lead to an organisation generating new data and knowledge that will have a commercial value. Reach has significantly increased the risks associated with producing substances, with the onus on the producer to assess and control risks deriving from their use.
Articles
Of potentially more relevance to the packaging sector are legislative sections covering ‘articles’. Registration of substances in articles is required if the substance is intended to be released under “normal or reasonably foreseeable conditions of use” and the substance is present in quantities greater than one tonne per producer per year. Notification to the new Chemicals Agency is required if the substance is on the candidate list for authorisation, is in quantities greater than one tonne, and is present in concentration greater than 0.1% by weight.
Notification is a safety net for the regulators. If they have concerns about a substance in an article they may still ask for it to be registered rather than notified. It is possible some packaging materials will be classed as articles.
Indirect impacts
Quality If substances made upstream are withdrawn on grounds of risk or economics then the alternative replacement substances may change the characteristics and potentially the quality of the packaging materials produced.
Revalidation of products Replacement of substances may trigger a requirement to revalidate products to comply with other regulations, such as food safety requirements, or industry or customer specifications. The revalidation process may be timely, costly and affect product development programmes.
Reputation, brand and transparency Ensure the Reach policy supports the firm’s overall business strategy and brand. Reach will mean that an organisation becomes aware of new information about substances which they may have to communicate to stakeholders, either to meet other regulatory requirements or customer expectations.
Reach will also promote greater transparency about chemical substances in products, their risks and impacts. For example, companies should be aware that while the science and risks assessments may show that a particular use of a substance is safe, pressure from customers downstream may lead to the spotlight falling on the product, especially where substances of high concern have been used.
What should firms be doing now?
• First, engage with the issue now. Develop approaches for analysing the commercial impacts.
• Map the structure of the supply chain and identify your chemical suppliers. Identify what uses substances are put to. Be prepared for substance withdrawal and timely communication with customers on the Reach strategy.
• Packaging firms may be able to capitalise on restrictions faced by competitors. For example, one packaging material could be subject to less scrutiny than another.
• Take control. You will need the commitment of senior management and specialist skills and resources to drive your Reach programme.
• Start to plan for the financial implications of Reach and focus on the areas of most value.
Mark Browning is a senior consultant in risk assurance services at PricewaterhouseCoopers
Browning: 'knowledge with commercial value'
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