Answer to Written Question: Harmful substances in face masks

(Source: European Parliament)

EN

E-001228/2021

Answer given by Mr Breton

on behalf of the European Commission

(28.5.2021)

The personal protective equipment (PPE) Regulation[1] lays down the health and safety requirements applicable to filtering face piece (FFP) masks. The PPE Regulation remains technologically neutral and does not prescribe any specific technical solutions.

Therefore, the PPE Regulation does not define what the exact constituent materials of PPE should be. Neither the PPE Regulation nor the relevant harmonised standards for filtering face pieces[2] impose the use of silver or titanium dioxide.

Manufacturers shall comply with requirements ensuring that the PPE and its constituent materials do not constitute a source of risks for the user’s health or safety[3] and shall take into due consideration thehighest degree of health and safety protection[4].

Reports appear to suggest that silver and titanium dioxide are mainly used in textile products, while FFP face masks are essentially made out of nonwoven fabrics. Nevertheless, the Commission services have initiated discussions with the industrial stakeholders in order to assess whether these substances are also used in the production of FFP masks. Furthermore, other kinds of face masks must be safe based on the General Product Safety Directive[5] or on the legislation on medical devices[6].

The Commission and the Member States are continuously deploying measures to ensure that only safe and compliant face masks are sold across the EU. The responsibility for market surveillance, including checks and sanctions, is entrusted to the Member States[7]. They have to exchange relevant inf


[1] Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC, OJ L 81, 31.3.2016, p. 51–98, ELI: http://data.europa.eu/eli/reg/2016/425/oj

[2] A number of harmonised European standards for filtering face pieces provide a presumption of conformity with the PPE Regulation. e.g. EN 149:2001+A1:2009, EN 140:1998 or EN 143:2000/A1:2006.

[3] c.f. essential requirements 1.2.1.1, 1.2.1.2 of Annex II to Regulation (EU) 2016/425.

[4] c.f. preliminary remark 3, Annex II to Regulation (EU) 2016/425.

[5] Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety, OJ L 11, 15.1.2002, p. 4–17.

[6] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ L 169, 12.7.1993, p. 1, ELI: http://data.europa.eu/eli/dir/1993/42/2007-10-11 and, from 26 May 2021, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance), OJ L 117, 5.5.2017, p. 1, ELI:  http://data.europa.eu/eli/reg/2017/745/2020-04-24

[7] In accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products, OJ L 218, 13.8.2008,
p. 30, ELI: http://data.europa.eu/eli/reg/2008/765/oj

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