Recent ATPs and the 8th Amendment

By: David Steinberg, Steinberg & Associates

Posted: January 29, 2010, from the February 2010 issue of Cosmetics & Toiletries.

In March 2009, the 8th Amendment to the Cosmetic Directive was approved by the European Parliament and the EU Council of Ministers. This approval is called a recast, as it changes the directive to a regulation. A directive must be incorporated into member state legislation in order to become a regulation, at which point it becomes binding as law in Europe. Since the amendment was approved, several presentations have been made on the regulation, which have raised a number of questions. However, to quote Yogi Berra, “It ain’t over ‘til it’s over.”

The 8th Amendment is not official until it is published in the Official Journal of the European Union and as of this writing, it has not. Reasons for the delay include the time it takes to translate the amendment into 22 official languages; however, the length of time the EU has taken to publish the amendment raises this author’s suspicion, since the EU publishes approximately 3–5 changes in other industries per day, many occurring in a short period of time. Therefore, this author will not comment on the recast until it is official.

[Editor’s note: The official publication of the new Cosmetic Regulations for the EU was issued on Dec. 22, 2009. Future columns will focus on this regulation in greater detail].

On Nov. 25, 2009, the EU Council of Ministers gave its final approval of the amendment. During the approval, the major dissent was from Germany, which objected to the requirement for the word nano to appear in brackets in the ingredient declaration for materials smaller than 100 nanometers.

Why does the Cosmetic Directive need the 8th Amendment? Some feel it is necessary since the directive has been changed 55 times, including seven amendments and 48 Adaptations to Technical Progress (ATPs). While the industry waits to see what this new amendment will bring, more ATPs have been published, as are described here. Science moves on contrary to political wishes.

Recent ATPs
On Feb. 4, 2009, an ATP was issued making changes to Annex II (the prohibited list) and Annex III (the restricted list). In Annex II, item number 1,370 was added, banning diethylene glycol except in trace amounts. Also, item 1,371 was added, banning phytonadione, also known as vitamin K1. These four restricted ingredients added to Annex III are described in Table 1.

On April 16, 2009, an ATP was published adding 17 hair dye substances to the restricted list. These substances are shown in Table 2. It should be noted that the use of INCI names rather than CI numbers is required for hair dyes in the EU. This ATP also deleted Annex III, part b, entry 55, columns c and d, as well as Part 2 of Annex III, numbers 7, 9, 14, 28, 47 and 58.

An ATP was published on Oct. 9, 2009, adding changes to items 26–43, 47 and 56 of Annex III. Previously, oral hygiene products formulated with fluoride were simply required to state that they contained the ingredient. Now, in addition to the statement contains sodium monofluorophosphate, any toothpaste with 0.1–0.15% fluorine, unless specified as for adults only, must include the following statement: Children of 6 years and younger: use a pea-size amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.