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Montenegro Further Aligns Chemical Safety with the EU

SafeGuardSElectrical & Electronics, Hardgoods, Softlines, Personal and Protective Equipment, Toys and Juvenile Products, AutomotiveDecember 16, 2022

SG 142/22

Montenegro has revised its lists of restricted chemicals and persistent organic pollutants to further align with those in the European Union. The revisions became effective on December 15, 2022.

In 2018, Montenegro issued the nation’s ‘Regulation on prohibited or permitted use, production and placing on the market of chemicals that pose an unacceptable risk to human health and the environment’ (‘the Regulation’, Official Gazette of Montenegro, Number 70/2018, 1344). The Regulation contains three Annexes for the management of chemicals:

  • Annex 1 ‘Chemicals that pose an unacceptable risk to health and the environment and whose use, production and placing on the market is prohibited or restricted’ (similar to ‘Restricted chemicals’ under Annex XVII of Regulation (EC) 1907/2006, Annex XVII of REACH. Consolidated version to October 2022)
  • Annex 2 ‘List of Prohibited persistent organic pollutant (POP) substances (similar to Annex I of Part A to Regulation (EU) 2019/1021 (POP Recast Regulation, Consolidated version to March 2021))
  • Annex 3 ‘Permitted values of VOC content in coatings (paints and varnishes)’

In 2020, Annex 1 to the Regulation was amended (Number 76/2020, 965) by including, among other things, new entries 72 (list of carcinogenic, mutagenic or toxic to reproduction (CMR) substances from the first column of Table in Part 4 of the attachment in this amendment) and 73 (3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) silanetriol, any of its mono-, di- or tri-O-(alkyl) derivatives (TDFAs)).

On December 7, 2022, Montenegro issued a piece of legislation to amend the Regulation (Official Gazette of Montenegro, Number 134/2022, 1865). The latest revision further aligns the (chemical) safety requirements with those in Annex XVII of REACH and the list of persistent organic pollutants in Annex I of Part A to the POP Recast Regulation in the European Union.

The latest amendment contains several important changes to Annexes 1 ‘Restricted chemicals’ and 2 ‘persistent Organic pollutants (POP) in the Regulation.

Annex 1 ‘Restricted chemicals’ to the Regulation, as amended (Number 76/2020, 965), contains several important changes. It: 

  • Deletes entry 68 (PFOA, its salts and PFOA-related substances). Unlike entry 68 to Annex XVII of REACH in the EU, Montenegro has not replaced this entry with C9-C14 perfluorocarboxylic acids (C9-C14 PFCA), their salts and C9-C14 PFCA-related substances in this amendment
  • Adds entries 74 (diisocyanates), 75 (substances for tattooing with corresponding Table for the list of substances with special concentration values in Part 5 of the Regulation) and 76 (N,N-dimethylformamide)
  • Updates the list of harmonized methods for azocolorants and azodyes under entry 43 (Table 9)

Annex 2 (List of Prohibited POP substances) to the Regulation contains several changes. It:

  • Inserts the following substances:
    • Bis(pentabromophenyl) ether (decabromodiphenyl ether, DecaBDE)
    • Pentachlorophenol (PCP), its salts and esters
      • ≤ 5 mg/kg in substances, mixtures or articles
    • Dicofol
    • Perflurooctanoic acid (PFOA), its salts and PFOA-related compounds with certain derogations
  • Allows up to 500 mg/kg for the sum of tetra-, penta-, hexa-, hepta- and DecaBDE in mixtures or articles

It is interesting to note that Montenegro’s latest list of restricted chemicals, in Annex I to the Regulation, requires a limit of no more than 0.1% for phenylmercury compounds (entry 62) as opposed to 0.01% for the same entry under Annex XVII of REACH. Additionally, the current entry 22 (PCP, its salts and esters) may be removed in the future as these substances are now regulated in Annex 2 for POP chemicals.

The latest amendment became effective on December 15, 2022 – the eighth day following the day of its publication in the Official Gazette of Montenegro.

For enquiries, please contact:

Dr. Hingwo Tsang
Global Information and Innovation Manager
t: +852 2774 7420

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