Regulatory Review: The Impact of REACH on the United States

By: David C. Steinberg, Steinberg & Associates

Posted: November 26, 2008, from the December 2008 issue of Cosmetics & Toiletries.

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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.