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:

• listed in the European Inventory of Existing Commercial Substances (Einecs);
• manufactured in the Community, but not placed on the market before Reach;
• or placed on the market in the Community, before Reach and notified.

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.

Animal Testing

The Cosmetics Directive seeks to phase out animal testing of cosmetics. Animal testing of finished cosmetic products has been prohibited since September 2004, with a timetable to end such testing on cosmetic ingredients. It prohibits "the marketing of cosmetic products containing ... ingredients or combinations of ingredients which, in order to meet the requirements of this Directive, have been the subject of animal testing..." The Cosmetics Directive establishes a prohibition of testing of finished cosmetic products and cosmetic ingredients on animals (testing ban) and a prohibition of EU-marketing of finished cosmetic products and their ingredients that were tested on animals (marketing ban). The testing ban on ingredients or combination of ingredients will apply "as soon as alternative methods are validated and adopted," but with a maximum cut-off date of six years after entry into force of the directive irrespective of the availability of alternative non-animal tests. The marketing ban is in effect from Mar. 11, 2009, for tests on all human health effects except repeat-dose and reproductive toxicity and toxicokinetics. For these, the deadline is Mar.11, 2013.
After this date, if a substance is tested because Reach mandates it, would this result in the substance being prohibited for use in cosmetics? Common sense and natural justice would say "no". However, in 2005, the French government brought a case before the Council seeking the annulment of Article 4a of the Cosmetics Directive. This action was dismissed. Unless challenged, this stands as the highest court ruling on the conflict between Reach and the Cosmetics Directive, and any tests conducted using vertebrate animals after Mar. 11, 2013 for Reach would debar that substance from cosmetics use. As the Reach testing schedule runs to 2018, the consequences seem obvious - the chemical industry may be required to run tests to comply with one law that result in its products being prohibited under another.

Conclusions

Reach was designed to achieve certain objectives, which are spelled out in the recitals.
"... high level of protection of human health and the environment ... free movement of substances ... enhancing competitiveness and innovation ... promote development of alternative methods for the assessment of hazards ..."
"... efficient functioning of the internal market for substances ..."

Cosmetics, with a long history of safe use, have been caught up in another regulation. Time will tell how much this will impact the industry.