Argentina has enacted a comprehensive operational regulation for primary batteries and cells, establishing mandatory conformity assessment, certification, labeling, and quality requirements. The regulation applies to all primary batteries and cells, as well as products containing them, regardless of whether the batteries are easily removable. Exclusions include primary lithium batteries, rechargeable batteries, batteries in non-commercial medical or research devices, and samples for testing.

Manufacturers and importers must ensure compliance through a sworn declaration of conformity and either a test report or product certification under recognized ISO/IEC 17067 schemes. Laboratory testing must address heavy metal content (mercury, cadmium, lead), minimum average duration, and marking requirements, with reports valid for one year and certificates for up to three years, subject to periodic surveillance.

The regulation mandates detailed labeling on each battery or its primary packaging, including brand, model, origin, and expiration or manufacturing date. A conformity mark is required on all regulated products, except for devices containing batteries, where it is optional. Strict prohibitions apply to products listed in Annex II of Resolution 299/2021 from the former Ministry of Environment and Sustainable Development.

Compliance is monitored through documentary controls and market inspections by the Secretariat of Tourism and Environment and the Secretariat of Industry, Commerce and Small and Medium Enterprises. Violations are subject to sanctions under Law 24.240 and Decree 274/2019, with additional civil, administrative, or criminal liability as applicable.

This regulation is classified as High Impact due to its mandatory nature and broad applicability across the battery and electronics sectors.

Key reasons for high impact:

• Mandatory conformity assessment, certification, and labeling for all primary batteries and products containing them.
• Strict technical requirements for heavy metal content, minimum duration, and hermeticity.
• Exclusion and prohibition of certain battery types and products.
• Comprehensive post-market controls and documentary requirements.

Who is affected?

Manufacturers, importers, distributors, retailers, certification bodies, and laboratories involved with primary batteries and products containing them.

Conclusion:

Immediate compliance actions are required for all stakeholders in the battery supply chain, with significant operational and documentation changes necessary to meet the new regulatory requirements.