1.-(1) These Regulations may be cited as the Cosmetic Products (Safety) (Amendment) Regulations 1998 and shall come into force on 28th August 1998.

2. The Cosmetic Products (Safety) Regulations 1996(3) are amended as follows-

• (a)

  in regulation 2(1), in the definition of "the Directive", by deleting the word "and" before "Commission Directive 97/45/EC"(4) and by adding the words ", and Commission Directive 98/16/EC"(5) at the end of that definition;

  (b)

  in regulation 4, by adding the following after paragraph (2)-

  "(2A) Subject to paragraphs (2B) to (2D) below, no person shall supply a cosmetic product which contains any of the following substances, or any ingredient derived from any of those substances, namely-

  (a)the skull, including the brain and eyes, tonsils and spinal cord of-

  (i)any bovine animal which, at its death, was aged over 12 months, or

  (ii)any ovine or caprine animal which, at its death, was aged over 12 months or had a permanent incisor tooth erupted through its gum; or

  (b)the spleen of any ovine or caprine animal.

  (2B) For the purposes of paragraph (2A) above, no account shall be taken of any substance referred to in that paragraph which is present in the cosmetic product only as a trace which could not reasonably have been removed during or after manufacture.

  (2C) Paragraph (2A) above shall not prohibit the supply of a cosmetic product which contains any tallow derivative so long as the relevant method set out in Schedule 5A was used in the manufacture of that derivative and the manufacturer of the derivative has certified that that method was used in its manufacture.

  (2D) Paragraph (2A) above shall not prohibit the supply of any cosmetic product which contains any substance or ingredient referred to in that paragraph but which was manufactured before 1st April 1998.";

  (c)

  in regulation 5(1), by inserting after the words "not being a substance" the words "or ingredient referred to in regulation 4(2A) or a substance";

  (d)

  in Part I of Schedule 4, by deleting entry number 53(1) and substituting the following-

  "53

  Benzethonium chloride (INN) [Benzethonium chloride]

  Products rinsed off after use

  0.1 per cent

  -

  -"; and

  (e)

  by adding the following Schedule after Schedule 5-

  Regulation 4(2C)

  "SCHEDULE 5AMETHODS OF MANUFACTURE OF TALLOW DERIVATIVES

  The following are the methods of manufacture referred to in regulation 4(2C)-

  • (a)

    Transesterification or Hydrolysis at at least 200°C, 40 bars (40,000 hPa) for 20 minutes (glycerol and fatty acids and esters);

    (b)

    Saponification with sodium hydroxide solution, c(NaOH)=12 mol/l (glycerol and soap):-

    (i)

    Batch process: at 95°C for three hours, or

    (ii)

    Continuous process: at 140°C, two bars (2,000 hPa) for eight minutes or equivalent conditions.".

Explanatory Note

(This note is not part of the Regulations)

These Regulations amend the Cosmetic Products (Safety) Regulations 1996 (S.I. 1996/2925) ("the principal Regulations").

The Regulations implement Commission Directive 98/16/EC (OJ No. L77, 14.3.1998, p.44) to prohibit the supply of cosmetic products containing a number of materials derived from certain bovine, ovine and caprine animals or ingredients derived from such materials. The prohibition does not apply to products manufactured before 1st April 1998. Nor does it apply if the materials are present only as a trace and could not reasonably have been removed during or after manufacture. Further, cosmetic products containing tallow derivatives may nonetheless be supplied if specified methods were used in the manufacture of those derivatives and if the manufacturer of those derivatives has certified that those methods were used.

The Regulations also amend Part I of Schedule 4 to the principal Regulations to replace entry number 53 relating to benzethonium chloride. This corrects an error in the Cosmetic Products (Safety) (Amendment) Regulations 1997 (S.I. 1997/2914).