“REACH is affecting our business substantially – although a company such as Firmenich had to register less than 10 substances for 2010", said Grell.
He went on to explain that with the registration process, the company has to first verify the work flow of all chemical substances, as well as ensuring the transparency of all its suppliers in relation to their compliance with REACH.
Once this stage is complete, there follows significant work involving dossier registration, including substance identification and data gap filling, toxicity testing, exposure scenario and CSR preparation, and final clarifications.
Years of long, hard work...
Switzerland-based Firmenich, which is one of the biggest fragrance and flavors players in the world, began to work towards REACH compliance back in 2007 and so far Grell estimates that the cost to the company has averaged €2m - €3m a year.
But in many ways this is still the beginning because the recent registration phase deadline was only for first tier substances, with annual production/importation volumes greater than 1,000 tons or 100 – 1,000 tons classified as R50/53 or all CMR 1&2 above 1 ton.
“We are now preparing for the second phase – 2013 - substances in the tonnage band 100 – 1,000 tons, which accounts for approximately 20 substance that Firmenich covers, and also the third phase with a 2018 deadline for 200 substances in the band of 1 – 100 tons per year,” Grell said.
Two more important registration deadlines
These two deadlines will see Firmenich and the industry registering approximately 900 substances during this period, and for which a lot of the necessary toxicological data is lacking. Grell estimates that over the next ten year period this will add up to an additional cost to the company of €30m.
“The efforts involved in REACH reveal a lot of toxicological data which is not necessarily relevant to the exposure level in cosmetic products because the REACH system is very hazard driven and does not consider risk aspects sufficiently,” Grell said.
“As a consequence we are likely to lose several newly CMR classified substances, although the cosmetics industry could prove safe usage in consumer products. This is a pity, but we will have to face it and live with the consequences.”
REACH compliance strategy
Grell, who is the vice president, corporate product safety & regulatory affairs, Firmenich, recommends these six points as a successful way of fulfilling REACH compliance requirements.
- Understanding the flow of purchased raw materials
- Understanding REACH activities of your suppliers and deciding whether you can trust them
- If you need to register, identify your substance in detail so you know what you are handling and who your potential co-registrants are
- Determine data gaps and fill them in the most pragmatic manner and avoid unnecessary testing
- Find pragmatic solutions with co-registrants, build trust, and just purchase the dossier from the lead registrant without too much interference, if leadership and expertise is confirmed.
- Communicate along the supply chain not forgetting your clients