# Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (Text with EEA relevance), Division 3: RIGOROUS PROCESSES FOR TALLOW DERIVATIVES AS REFERRED TO IN ARTICLE 1, PARAGRAPH 4, OF THIS REGULATION

Extent: E+W+S+N.I.

Trans-esterification or hydrolysis at not less than 200 °C for not less than 20 minutes under pressure (glycerol, fatty acids and fatty acid esters production),
Saponification with NaOH 12 M (glycerol and soap production)
Batch process: at not less than 95 °C for not less than 3 hours,
Continuous process: at not less than 140 °C, under pressure for not less than 8 minutes or equivalent,
Distillation at 200 °C.

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Source: https://www.legislation.gov.uk/eur/2012/722/annex/I/division/3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-722/annex-I/division-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.