S.L. 449.35 Art. 28to either of "mutagenic" Directive (b) 29. accordance regulations and 30. The for in determination are not 31. The for in assuming cannot exceed 32. The for in substance in quantity and either by an diffusion of a material experimental 33. 74560, 75100, verification verification of been in contact l

The substances referred to in paragraph 26(b) shall not belong the following categories:

(a) substances classified as proved or suspect "carcinogenic", or "toxic to reproduction" substances in Annex I to Council ‡ 67/548/EEC ( );

†OJ L 165, 30.4.2004, p. 1, as corrected by OJ L 191, 28.5.2004, p. 1. ‡OJ 196, 16.8.1967, p. 1. substances classified under the self-responsibility criteria as "carcinogenic", "mutagenic" or "toxic to reproduction" according to the rules of Annex VI to Directive 67/548/EEC.

Verification of compliance with the migration limits shall be carried out in with the rules laid down in the Sixth and Seventh Schedules to these the further provisions set out in Part I of this Schedule. verification of compliance with the specific migration limits provided paragraph 29 shall not be compulsory, if the value of overall migration implies that the specific migration limits referred to in that paragraph exceeded.

verification of compliance with the specific migration limits provided paragraph 29 shall not be compulsory, if it can be established that, by complete migration of the residual substance in the material or article, it the specific limit of migration. verification of compliance with the specific migration limits provided paragraph 29 may be ensured by the determination of the quantity of a the finished material or article provided that a relationship between that the value of the specific migration of the substance has been established adequate experimentation or by the application of generally recognised models based on scientific evidence. To demonstrate the non-compliance or article, confirmation of the estimated migration value by testing is obligatory. Notwithstanding paragraph 29, for phthalates (Ref. No 74640, 74880, 75105) referred to in the Part III of this Schedule, Part B, the of the SML shall only be performed in food simulants. However, the SML may be performed in food where the food has not already with the material or article and is pretested for the phthalate and the statistically significant or greater than or equal to the limit of marketing stages other than the retail stage, plastic materials and as the substances intended for the manufacturing of those materials shall be accompanied by a written declaration in accordance with Regulation (EC) No 1935/2004.

declaration referred to in paragraph 34 shall be issued by the business shall contain the information laid down in Part VIa of this Schedule.

Appropriate documentation to demonstrate that the materials and articles as substances intended for the manufacturing of those materials and articles the requirements of this Schedule shall be made available by the operator to the national competent authorities on request. That shall contain the conditions and results of testing, calculations, other evidence on the safety or reasoning demonstrating compliance.