Regulation Rumbling - Reach now impacts not only the chemical industry, but also downstream users of chemicals, which are already under the control of other regulations creating conflicts.
In the EU, the cosmetics industry is regulated by the Cosmetics Directive (76/768/EC). This directive regulates cosmetics products placed on the EU market, irrespective of where they are made. However, before Reach substances used to formulate cosmetics were only regulated in the EU under chemicals regulations up to the point where they are formulated into cosmetics. Finished cosmetics were not subject to chemical control regulations until Reach came into force. This change has already profoundly impacted the cosmetics industry and will continue to do so.
Registration And Pre-registration
Unlike under the old regulations, a substance that is part of a cosmetics product imported into the EU at >1 ton must now be pre-registered or registered. Pre-registration allows an importer to take advantage of the extended registration timetable (the so-called phase-in provisions). Any substance meeting the specified requirements was eligible for pre-registration provided it was:
Most raw materials for cosmetics met the first criterion, i.e. were listed on Einecs. However, even the simple matter of pre-registration and registration imposed a huge administrative burden on the industry, besides what they were already doing for compliance with cosmetics regulations. For pre-registration alone, it is estimated that over 3,000 substances were pre‑registered, and the burden was not proportionate to company size - many smaller cosmetics manufacturers had to pre-register as many substances as their larger cousins. Pre-registrants must then determine which of these substances to support through to full registration.
Testing And Registration Costs
In theory, the testing requirements for Reach are tiered; higher tonnage substances carry the greatest testing and registration cost burden.
However, many of the substances in the >1000 tons band have already been through various High Production Volume programs, which are likely to have generated data for many of the Reach endpoints. The major burden under Reach is likely to fall on substances in the 100 - 1000 tons range. Table 1 shows possible test cost scenarios for each tonnage band. These are worst-case scenarios, as they are based on the assumption that a substance had to have every Reach endpoint addressed, with no historical data, read across, waivers or tests being otherwise derogated. Nonetheless, they illustrate the possible costs that industry has to prepare for.
Substances Not On Einecs
Pre-registration provisions were established under Reach to allow for an extended registration timetable for substances either already on the EU market or previously EU-manufactured. For a substance to qualify for this extended registration timetable, it must meet one of the specified "phase in" criteria. For cosmetics, this leaves a gap. Many non-Einecs listed substances had been imported into the EU as part of cosmetics formulations. To meet the requirements of pre-Reach chemicals regulations, a cosmetics ingredient was only required to be notified if the substance itself is marketed in the EU. If only marketed as part of a cosmetics formulation, it was not a requirement for it to be Einecs-listed or notified. However, under Reach, substances imported into the EU as part of cosmetic finished products will have to be registered. Many organizations have pre-registered these substances even though their eligibility is unclear.
Rationalization Of Raw Materials
Reach was established to regulate and control around 30,000 existing chemicals. To achieve this, the Commission has implemented the most far reaching legislation that has ever been implemented anywhere. This will inevitably lead companies to look critically at their substance portfolios. Additionally, some substances - most notably preservatives - are already under the strain of other EU and non-EU legislation. If a company wants to market a substance in Europe as a preservative for say cosmetics and liquid laundry detergents, the substance has to be: registered under Reach, registered as an in-can preservative under the Biocidal Products Directive, and approved for use as a cosmetics preservative.
Three separate pieces of legislation, with overlapping, but often not harmonized requirements just to gain access to two markets. It is no surprise that the number of preservatives and biocides available to the EU market is falling, and likely to fall further. Some experts have predicted that the fall out from these three pieces of legislation will result in 80 % of preservatives/biocidal actives becoming unavailable within the next ten years. This legislation makes defense of existing substances prohibitively costly and makes entry into the market expensive for new chemistry. Up-front costs can exceed $0.5 million, with no guarantee of approval at the end of the process.
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