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Parliamentary questions
30 August 2017
E-004456/2017
Answer given by Mr Andriukaitis on behalf of the Commission

The Commission is aware that Asia is the world's main producer and supplier of active pharmaceutical ingredients including antibiotics, and shares the growing concern about the development and spread of antimicrobial resistance (AMR) in the environment due to discharges of antimicrobials and their metabolites from various sources including pharmaceutical production plants.

As a consequence, the Commission has launched several initiatives aimed at addressing these issues.

The Commission recently adopted its second AMR Action Plan(1) which includes specific actions to improve knowledge about the contribution of the environment to AMR, and to explore possibilities for taking appropriate measures. This includes developing a Strategic Approach to address the risks from pharmaceuticals in the environment.

The action plan also promotes actions and collaboration at global level. The synopsis report accompanying the action plan mentions that some options could relate to manufacturing effluents and to the collection of unused antimicrobials.

The existing Guidelines on Good Manufacturing Practice(2) for active substances require that sewage, refuse, and other waste in and from factory buildings and the immediate surrounding area should be disposed of in a safe, timely and sanitary manner.

Although not specifically mentioned in those guidelines, manufacturing facilities have to comply with local regulations to minimise the risk of contaminating the environment.

(1)A European One Health Action Plan against Antimicrobial Resistance https://ec.europa.eu/health/amr/sites/amr/files/amr_action_plan_2017_en.pdf
(2)https://ec.europa.eu/health/documents/eudralex/vol-4_en

Last updated: 4 September 2017Legal notice