Regulatory Review: The Impact of REACH on the United States

On Sept. 10, 2008, McKenna Long & Aldridge LLP, TSGE and Chemical Watch hosted a REACH conference in Arlington, Va., USA, for US businesses, titled “REACH in the Pre-registration Window and Beyond.” While this column will not focus on REACH legislation, it does report on several critical areas related to REACH that were discussed at this meeting.

US Exemption from TSCA
Rep. Diana DeGette, (D-Colorado), chief deputy whip of the House of Representatives’ majority party and vice-chair of the House Committee on Energy and Commerce (HCEC), was the keynote speaker. The HCEC is chaired by Rep. John Dingell (D-Michigan), who is in charge of the proposed US Food and Drug Administration (FDA) Globalization Act of 2008. Had this act been passed, it would have majorly impacted the cosmetics industry in a negative way.1 This bill is dead until 2009, at which time it may be reintroduced again to the subcommittee and, if approved, it would then move on to the full committee and forward to Congressional ratification.

The HCEC also oversees the Toxic Substance Control Act (TSCA) of 1976. Since all products regulated by the FDA are exempt from TSCA, this act has never been a major topic for the cosmetics and personal care industry, which is why pre-approval or preregistration of cosmetic ingredients in the United States is not required.

DeGette’s comments on the TSCA were of interest mostly to the chemicals industry, which represented the majority of attendees at the conference, though the cosmetics industry was represented (there may have been three of us). She discussed the globalization act, which, as noted, is on hold until 2009. However, of concern to the cosmetics industry and its ingredient suppliers is the review of the TSCA.

Reforming the TSCA is a top priority of the HCEC, and DeGette expects legislation to be resolved in 2009. Since cosmetic ingredients are currently exempt from the TSCA and its pre-notification requirements, new ingredients have been introduced with little cost or restriction; they merely have to be safe and have a target audience willing to buy them. In Canada and the EU where there is no such exemption, the introduction of new ingredients becomes more difficult. This is one reason why the United States has taken such an active role in developing new cosmetic materials. New ingredients are tried in the United States, and if successful, suppliers then invest in global approvals. The exemption of FDA-regulated industry from the TSCA may be on the committee’s agenda.

The industry should watch this TSCA reform so that the United States maintains its exemption. Of particular concern to DeGette was the need to anticipate and stop any and all state legislation that controls chemicals, such as California’s Proposition 65.

As for the food safety bill, to which the new cosmetics regulation was attached, it will be on the Congressional agenda as soon as the incoming electorate convenes in January. DeGette feels that a consensus bill will be reached that deals strictly with foods, much to the cosmetic industry’s relief. Again, the industry must be on top of this because nongovernmental organizations (NGOs) will likely propose more regulations for cosmetics and cosmetic ingredients with the ultimate goal being the pre-approval of all chemicals and cosmetics. This would have devastating effects on the industry and innovation.

Registration of Non Phase-in Substances
Jeffrey Weiss, senior director of the Technical Barriers to Trade Committee of the Executive Office of the President, noted that REACH is a barrier to trade. Cosmetic ingredients used in non-EU countries that are exported into the EU in the form of finished cosmetics were specifically noted by Weiss. These chemicals are not required to obtain European List of Notified Chemical Substances (ELINCS) registrations, but also do not meet the definition of existing chemicals, which requires they have EINECS numbers.²

The Personal Care Products Council brought it to Weiss’s attention that these chemicals are legally allowed in the EU and should therefore be eligible for preregistration. Negotiations are continuing and hopefully will be resolved by Nov. 1, 2008, the deadline for pre-registration under REACH, although an extension is possible. It was proposed in June 2008 that manufacturers of these chemicals sign up on REACH-IT to send an inquiry with supporting information, demonstrating that the substances were lawfully on the EU market before June 1, 2008. The European Chemicals Agency (ECHA) will determine whether the chemicals are eligible for preregistration and if not, registration will be required immediately.

This produces a dual burden; first on the ingredient manufacturer, then on the company exporting the cosmetic containing the ingredient to the EU. Chemical suppliers must ask their customers if their non-EU ingredients are used outside the EU, whether the finished goods are shipped into the EU, and in what volume the ingredients are shipped (taking a three-year average of the amount placed on the EU market). Manufacturers must know how much of the non-EU produced chemical is used in its products that are shipped into the EU and inform its vendors.

The SIN List
The most controversial speaker at the conference was Daryl Ditz, a senior policy advisor for the nonprofit Center for International Environmental Law. He spoke about the Substitute It Now (SIN) list that was released on Sept. 17, 2008. Ditz gave no indication of what chemicals would be on the list, but said these were chemicals that the International Chemical Secretariat (ChemSec) deemed to be “of such high concern that they need to be removed from the market even before REACH has had a chance to review them.”

The SIN list is an NGO-driven project to catalyze the transition to toxic-free products and processes. This list was developed in collaboration with an NGO advisory committee that included: the European Environmental Bureau, the World Wildlife Fund European Policy Office, Friends of the Earth Europe, Greenpeace European Unit, Instituto Sindical de Trabajo Ambiente y Salud, The European Consumer’s Organization, Women in Europe for a Common Future, The Center for International Environmental Law and The Health and Environment Alliance. The list of chemicals can be found at, www.chemsec.org/list/documents/080917_reach_sin_list.pdf.  

SIN chemicals are listed by their CAS number, EINECS number, chemical (not INCI) name, and reason for inclusion. These reasons could include:

a) Carcinogenic Category 1 or 2 (C);
b) Mutagenic Category 1 or 2 (M);
c) Toxic for reproduction Category 1 or 2 (R);
d) Persistent, bioaccumulative and toxic (PBT);
e) Very persistent and very bioaccumulative (vPvB); and
f) Equivalent level of concern, such as endocrine disruptors (Equivalent level of concern).

There are 267 chemicals on the initial list. All of these chemicals meet the REACH definition for Substances of Very High Concern (SVHC) and are subject to the greatest scrutiny. The ECHA will create a specific list of these undesirable substances that will compel importers, producers and downstream users to seek special authorization for continued use. Authorization may be denied because REACH contains a provision that could replace some of these dangerous substances with safer alternatives. ChemSec released this SIN list in anticipation of the REACH SVHC list (see Table 1). The SIN list includes the following cosmetic ingredients:

• Lead di(acetate) (INCI: Lead acetate)³
• Dibutyl phthalate (INCI: Dibutyl phthalate)
• Triclosan (INCI: Triclosan)
• Octamethylcyclotetrasiloxane (INCI: Cylcotetrasiloxane)

The use of lead acetate, a FDA-permitted colorant, has probably disappeared from cosmetics in the United States since it is on California’s Proposition 65 list. Dibutyl phthalate is also disappearing after its ban in the EU and its listing on Proposition 65,⁴ even though it has safely been used for years in nail polish. Cyclotetrasiloxane, which is the D₄ version of cyclomethicone, has faced problems in Canada,¹ thus most users in the United States have formulated without it.

It is critical that companies use its specific name instead of the old INCI name of cyclomethicone because ChemSec lists cyclomethicone as an alternative name for octamethylcyclotetrasiloxane; thus using cyclomethicone or the incorrect term could cause NGOs to focus on a mislabeled cosmetic.

Triclosan is a commonly used ingredient in deodorants and in US over-the-counter (OTC) drugs, such as health care antiseptics and toothpaste. This action by ChemSec could put additional focus on formulating without triclosan. The ingredient has come under fire for reasons such as accumulating in sewage treatment plants and causing bacterial resistance and possible endocrine disruption. Also on the SIN list are ethylene oxide and formaldehyde (anhydrous gas), which are frequently used as building blocks for many cosmetic ingredients.

The anhydrous gas formaldehyde is the starting material for methylene glycol, which is used in nail hardeners and preservatives such as imidazolidinyl urea, quaternium-15, DMDM hydantoin and diazolidinyl urea. It is one of the critical starting materials for Reppe chemistry, which is used to create many ingredients such as preservatives, hair fixatives, thickeners and solvents. Ethylene oxide (EO) is the starting material for preservatives such as phenoxyethanol, alkanolamines (including triethanolamine) and ethyloxylated chemicals that act as emulsifiers, surfactants, thickeners, humectants and so forth. It would be nearly impossible to formulate cosmetic products without EO-derived ingredients.

A great sense of fear was felt at the conference that the press would obtain this SIN list and begin denouncing products that contain these ingredients or their derivatives. However, the publication of the list was overshadowed since it was released on the same day that the US financial crisis erupted. Should the press shift its focus and pick up on this list, the cosmetic industry will face great challenges.

Addition to the Exemption from REACH List
A proposal to amend Annexes IV and V, which are exempt from REACH registration and preregistration, includes several ingredient additions: sorbitol, ascorbic acid, glucose, fructose, lysine, sucrose, tocopheryl acetate, methionine, lactose, mannitol, glyceryl stearate, calcium pantothenate, phenylalanine, sodium glyconate, sorbitan oleate, lecithin, phosphatidylcholine, hydrogenated tallow, dextrin, Oryza sativa (rice) starch, Solanun tuberosum (potato) starch, tapioca starch, Tritium vulgare (wheat) starch, Zea mays (corn) starch, maltodextrin, methyl cocoate, hydrogenated tallow glycerides, glyceryl oleate, C10-18 triglycerides, triglycerides of C16-18 saturated and C18 unsaturated fatty acids, vegetable fats/oils/waxes, animal fats/oils/waxes, fatty acids from C6 to C24 and their potassium, sodium, calcium and magnesium salts, and glycerin.

Plant-derived Ingredients
Other important issues that arose at the conference, one being plant-derived ingredients. In 1900, the Lacey Act, named after Rep. John Lacey (D-Iowa), was passed into law in the United States, prohibiting the transportation of illegally captured or prohibited animals across state lines. It was the first federal law protecting wildlife and is still in effect, though it has been revised several times. Today the law is primarily used to prevent the importation or spread of potentially dangerous non-native species.⁵

The Food, Conservation and Energy Act of 2008 amended this act. In section 8204 under illegal logging practices, plants are defined to include roots, seeds, parts or products of plants and trees. The bill requires importers to the United States to submit a declaration to the US Department of Agriculture (USDA) with the scientific name including genus and species and country of origin. This complex legislation could include plant extracts, oils, etc., imported as raw materials or in finished cosmetics. It can also include pacakaging. Since there are fines for violations, it is important for those potentially affected to learn the requirements, including first and foremost, that the US importer is responsible for registering. The declarations for such materials will be required as of Apr. 1, 2009. There are still many grey areas on what is covered and how it may affect the industry.

Sunscreens
On Sept. 12, 2008, the FDA announced that seven UV filters passed the first stage of the Time and Extent Application (TEA) for approval in the United States (Table 2). TEA is a four-stage process, including: Stage One, the formal submission of a TEA showing that a product meets the requirements spelled out in the Code of Federal Regulations;⁶ Stage Two, submission of safety and efficay data on the active ingredient and its finished drug use; Stage Three, the announcement of a comment period to accept and approve the TEA and amend the OTC Monograph; and Stage Four, amending the Final (or TFM) Monograph to allow the use of the active ingredient. So far, none have passed the second stage and thus cannot be used.

Conclusions
It is clear that REACH will start to draw a reaction from NGOs in the United States. Since REACH will replace the old EU chemicals regulation in 2009, Congress will look to TSCA, the original of all chemical regulations, for possible revisions. The NGOs will be out in full force, as they were in the EU, which lead to the passage of REACH. What is clear, by way of REACH’s example with its numerous fees and ancillary costs, is that the current global financial climate will not be taken into consideration. So far as the NGOs are concerned, the industry can pay.

Congress will examine the food safety bill; it would benefit the industry if Congress did not look at cosmetics regulation. The SIN list is troubling and creates problems in formulating without ingredients that use formaldehyde and ethylene oxide as starting materials; it may end in REACH authorization rather than a total ban.

Finally, the changes to the Lacey Act may or may not affect the cosmetics industry; much more must be learned before action can be taken.

References
Send e-mail to [email protected].
1. DC Steinberg, Regulatory Review, Cosm & Toil 123(8) 24 (Aug 2008)
2. DC Steinberg, Regulatory Review, Cosm & Toil 113(4) 31-33 (Apr 1998)
3. US Code of Federal Regulations, 21CFR 73.2396, available at: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=73.2396 (Accessed Oct 24, 2008)
4. European Commission Directive 2004/93/EC, Annex II, number 675, available at: www.safecosmetics.org/docUploads/EU_Cosmetics_Directive_Sep-2004.pdf (Accessed Oct 24, 2008)
5. www.animallaw.info/articles/ovuslaceyact.htm (Accessed Oct 24, 2008)
6. US Code of Federal Regulations, 21CFR 330.14, available at: www.fda.gov/OHRMS/DOCKETS/98fr/04d-0277-gdl0001.pdf(Accessed Oct 24, 2008)