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.
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 (shown as part I and part II due to file sizes). 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.
On Oct. 12, 2009, two changes were made to Annex III, again involving hair dye chemicals. These changes are shown in Table 3. First, the following phrases were replaced in part 1 of Annex III, in column b of reference number 8: p-Phenylenediamine, its N-substituted derivatives and its salts; N- substituted derivatives of o-Phenylenediamine (5), with exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II; and replaced with: N-substituted derivatives of p-Phenylenediamine and their salts; N-substituted derivatives of o-Phenylenediamine (5), with exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311 and 1312 in Annex II. Also, in column b of reference 9, the following phrases: Methylphenylenediamines, their N-substituted derivatives and their salts (1) with the exception of substances under reference numbers 364, 1310 and 1313 in Annex II; were replaced with: Methylphenylenediamines, their N-substituted derivatives and their salts (1), with the exception of the substance under reference number 9a in this Annex and substances under reference numbers 364, 1310 and 1313 in Annex II.
Finally, in reference number 14, column d and paragraph a in column f, the 0.3% maximum authorized concentration in finished cosmetic products was deleted.
Hair Warning in Annex III
The most recent ATP was published on Oct. 28, 2009. This amended Annex III, Parts 1 and 2, to include warnings for safety.
In Part 1 under references 8 and 8a, in column f, points (a) and (b), the text can cause an allergic reaction is replaced by the warning shown in Figure 1. Under reference 9, the text in column f is replaced with the warning shown in Figure 1 but the text includes the additional statements: Contains phenylenediamines (toluenediamines). Do not use to dye eyelashes or eyebrows; For professional use only; and Wear suitable gloves. Since these hair dyes are to be used by professionals who are exposed to them more often than consumers, the warnings are included to caution against using the dyes on hair anywhere other than on the head.
Under reference 9a, the text in column f is again replaced by the warning in Figure 1 with the same statements added in reference 9; also, under references 8a and 9a, in column f, points (a) and (b), the phrase The mixing ratio is printed on the label is added.
Under reference 16 in column f, and under reference numbers 202 and 203, in column f, point (a), the phrase Can cause allergic reaction is replaced by the warning in Figure 1; the same warning also is added under reference number 22, in column f, sub-points 1 and 2 of point (a), and under references 193 and 205, in column f, point (a). In part 2 of Annex III, the phrase Can cause allergic reaction is replaced by the warning in Figure 1 in the following instances: in reference 3 of column f, points (a) and (b); under references 5, 6, 12, 19, 21, 22, 25 and 33, in column f; and under references 10, 11 and 16, in column f, point (a).
Under reference numbers 4, 20, 26, 32, 34- 39 and 44, column f, the warning in Figure 1 is added. Also, under references 10, 11 and 16, column f, point (b) is deleted; and under reference numbers 27, 48 and 56, in column f, and under reference numbers 31, 49, 50 and 55, in column f, the warning in Figure 1 is added.
On Dec. 16, 2009, another ATP was issued extending the provisional listing of the 31 hair dye substances in Annex III, part 2, for another year.
Although the recast of the EU Cosmetic Regulations is intended to simplify the regulations, the recent ATPs confirm that the regulation will continue to be confusing and user-unfriendly. The EU Commission continues to add ingredients to its prohibited list in the order in which they are prohibited, which makes them difficult to search for and thus, comply with. One solution might be to place them in alphabetical order and rewrite the regulation each time there is a change. In this author’s opinion, the EU should always list the prohibited ingredients by INCI name; if the prohibited ingredients have no INCI name, they should not be on the list since they are not used in cosmetics.
The new warnings and pictogram for hair dyes will cause more clutter on packaging with no proof that the user will read or follow them. Further, all warnings must be in all 22 official languages, which will require the packaging to be much larger.
Finally, this author fully supports the banning of phytonadione or vitamin K1 since it has caused deaths in France from minuscule use levels in cosmetics. It also serves no function except for labeling claims.