The European Commission has proposed Commission Regulation (EU) to amend Annex XVII to REACH Regulation (EC) No 1907/2006 aiming to add the conditions of restriction lead (entry 63). The following is the highlight of the proposed amendments:

The following condition of restriction shall be added to entry 63 (lead) of Annex XVII after paragraph 10:

11. Shall not be used in articles produced from polymers or copolymers of vinyl chloride (PVC)

12. Shall not be placed on the market in articles produced from polymers or copolymers of PVC if the concentration of lead (expressed as metal) is equal to or greater than 0,1 % by weight of the PVC material.

13. Paragraphs 11 and 12 shall apply 24 months after this Regulation enter into force.

14. By way of derogation, paragraphs 11 and 12 shall not apply to:

a. the following rigid articles containing recovered rigid PVC until 15 years after this Regulation enter into force, provided that the concentration of lead (expressed as metal) does not exceed 2 % by weight of the recovered PVC material:

i. profiles and sheets for exterior applications in buildings and civil engineering works, excluding decks and terraces;

ii. decks and terraces, provided that the recovered PVC is used in the middle layer and is entirely covered with a layer of newly produced PVC or other material, which prevents leaching and formation of lead containing dusts during article service life;

iii. profiles and sheets for use in concealed spaces or voids in buildings and civil engineering works (ｗｈｅｒｅ they are inaccessible during normal use, excluding maintenance, for example, cable ducts);

iv. profiles and sheets for interior building applications, provided that the entire surface of the profile or sheet facing the occupied areas of a building after installation is produced using newly produced PVC or other material, which prevents leaching and formation of lead containing dusts during article service life;

v. multi-layer pipes (excluding pipes for drinking water), provided that the recovered PVC is used in the middle layer and–is entirely covered with a layer of newly produced PVC;

vi. fittings, excluding fittings for pipes for drinking water.

The concentration of lead, expressed as metal, in the layer that prevents leaching and formation of lead containing dusts during article service covering the recovered PVC in the above applications shall be lower than 0,1 % by weight of the material used in the layer.

b. the following flexible articles containing recovered flexible (soft) PVC - until 15 years after this Regulation enter into force, provided that the concentration of lead (expressed as metal) does not exceed 1 % by weight of the recovered PVC material:

i. mats for stables and greenhouses;

ii. noise insulation sheets;

iii. multilayer hoses, articles for roofing and waterproofing, for road furniture and traffic management and professional footwear. After 6 years this Regulation enter into force, this derogation shall only apply provided that the recovered PVC used in such articles is entirely enclosed with a layer of newly produced PVC or other material, which prevents leaching or formation of lead-containing dusts during article service.

The concentration of lead, expressed as metal, of other material that prevents leaching and formation of lead containing dusts during article service used in combination with recovered PVC in the above applications shall be lower than 0,1 % by weight of the other material.

c. PVC-silica separators in lead acid batteries, until 10 years after this Regulation enter into force.

d. articles covered by paragraph 1, in accordance with paragraphs 2 to 5, and by paragraph 7 in accordance with paragraphs 8 and 10.

e. articles within the scope of:

i. Regulation (EC) No 1935/2004;

ii. Directive 2011/65/EU;

iii. Directive 94/62/EC;

iv. Directive 2009/48/EC.

15. Suppliers of rigid and flexible PVC articles listed in paragraph 14(a) and (b) shall ensure, before placing those articles on the market, that they are visibly, legibly and indelibly marked as follows: ‘Contains recovered PVC’. The same marking shall be applied, before their placing on the market, to the packaging containing recovered PVC.

16. Suppliers of rigid and flexible PVC articles covered by paragraph 14(a) and (b) shall submit to national enforcement authorities upon request documentary evidence to substantiate the claims on the recovered origin of PVC in those articles. Certificates issued by schemes to provide proof of traceability and recycled content, such as those developed according to EN 15343 or similar standards, may be used to substantiate such claims for articles manufactured in the Union. Claims made on the recovered origin of PVC in imported articles shall be accompanied by a certificate issued by an independent third party.

17. The Commission shall review the derogation set out in paragraph 14(a) and (b) in accordance with Article 69 by [OP, please ｉｎｓｅｒｔ a date corresponding to 10 years after the entry into force of this Regulation].

18. Paragraph 12 shall not apply to articles for which it can be demonstrated that they had already been placed on the market before the date of 24 months after this Regulation enter into force.

19. Paragraphs 11 and 12 shall not apply to the following pigments:

a. lead sulfochromate yellow (EC No: 215-693-7);

b. lead chromate molybdate sulfate red (EC No: 235-759-9).

Note: Annex XVII: Restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles

• Regulation (EC) No 1935/2004: Regulation on materials and articles intended to come into contact with food
• Directive 2011/65/EU: Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS)
• Directive 94/62/EC: Directive on packaging and packaging waste
• Directive 2009/48/EC: Directive on the safety of toys

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