EU PPWR FAQs Updated August 2026 - Flipbook - Page 18
III.
SUBSTANCES OF CONCERN
1) In the definition of Substances of Concern (SoC), which refers to the ESPR, should
the conditions in Article 2(27) points (a), (b), (c), (d) of the ESPR be considered as
cumulative? How should the wording 8negatively affects the reuse and recycling of
materials in the product in which it is present9 be understood?
It is sufficient that only one of the conditions under points (a) to (d) of Article 2(27) ESPR is
fulfilled for a substance to be considered as a SoC4.
As regards the meaning of the wording 8negatively affects the reuse and recycling…9 the
Commission and the European Chemicals Agency (ECHA) are currently conducting a study on
identifying the SoC that could affect human health and impact packaging reusability and
recyclability.
2) What is the difference between substances and substances of concern (SoC)? Does the
Ecodesign for Sustainable Products Regulation (ESPR) and the PPWR address
substances of concern (SoC) in the same manner?
The definition of substances of concern (SoC) refers to the ESPR (Article 3(1), fourth paragraph of
the Regulation), which means that substances of concern are defined in the same manner in the
PPWR and the ESPR. The ESPR establishes the criteria for identification of substances of concern.
They are mainly based on their hazardous properties and classification in accordance with the CLP
Regulation5 but also include a reference to negative effects on the reuse and recycling of materials
in the product in which they are present6. The conditions are not cumulative, which means that if
one of the conditions is fulfilled, the substance is considered as SoC.
4
The ESPR FAQ can be found here: Circabc.
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC
and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31/12/2008, p. 1–1355).
5
6
According to Article 2, point (27) of ESPR, 8a substance of concern9 means a substance that:
a) meets the criteria laid down in Article 57 of Regulation (EC) No 1907/2006 and is identified in
accordance with Article 59(1) of that Regulation;
b) is classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 in one of the following hazard
classes or hazard categories:
a. carcinogenicity categories 1 and 2;
b. germ cell mutagenicity categories 1 and 2;
c. reproductive toxicity categories 1 and 2;
d. endocrine disruption for human health categories 1 and 2;
e. endocrine disruption for the environment categories 1 and 2;
f. persistent, mobile and toxic or very persistent, very mobile properties;
g. persistent, bioaccumulative and toxic or very persistent, very bioaccumulative properties;
h. respiratory sensitisation category 1;
i. skin sensitisation category 1;
j. hazardous to the aquatic environment 4 categories chronic 1 to 4;
k. hazardous to the ozone layer;
l. specific target organ toxicity 4 repeated exposure categories 1 and 2;
m. specific target organ toxicity 4 single exposure categories 1 and 2.
c) is regulated under Regulation (EU) 2019/1021; or
d) negatively affects the reuse and recycling of materials in the product in which it is present.
15
