NIS2 for Manufacture, production and distribution of chemicals
The entry names three activities and borrows from REACH the actors and the object they concern: manufacture of substances, distribution of substances or mixtures, and production of articles from substances or mixtures — an article being an object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition (REACH art. 3(3)).
Which entities are covered
Undertakings carrying out the manufacture of substances and the distribution of substances or mixtures, as referred to in Article 3, points (9) and (14), of Regulation (EC) No 1907/2006 of the European Parliament and of the Council and undertakings carrying out the production of articles, as defined in Article 3, point (3), of that Regulation, from substances or mixtures
Sub-sectors named in the annex
None. Annex II divides this sector into no sub-sectors: it names the types of entity directly.
Essential or important
An entity of this Annex II sector that is medium-sized or larger is important (art. 3(2)); a small or micro one is covered only under article 2(2) or 2(3). Whatever its size, an entity is essential where article 3(1)(e) to (g) applies: identification by the member state as an essential entity under article 2(2)(b) to (e), critical-entity status under Directive (EU) 2022/2557, or, where the member state so provides, earlier identification as an operator of essential services. An entity the member state identifies as an important entity under the same points is important (art. 3(2)).
Essential entities face ex ante and ex post supervision (art. 32, recital 122) and, for infringing article 21 or 23, administrative fines with a maximum of at least EUR 10,000,000 or 2% of the total worldwide annual turnover in the preceding financial year of the undertaking to which the entity belongs, whichever is higher (art. 34(4)); important entities face ex post supervision only (art. 33) and a maximum of at least EUR 7,000,000 or 1.4% of that turnover (art. 34(5)).
Traps specific to this sector
Trap 1
The annex joins manufacture of substances and distribution of substances or mixtures with ‘and’ and does not say whether an undertaking must carry out both or either. The actors come from REACH: a manufacturer is established within the Community and manufactures a substance within the Community (art. 3(9)); a distributor is established within the Community and only stores and places on the market a substance, on its own or in a mixture, for third parties — retailers included (art. 3(14)). The size rule of article 2(1) applies as in every sector.
Trap 2
Questions the text leaves open: importers (REACH art. 3(11)) and downstream users such as formulators (art. 3(13)) are not named; how far ‘production of articles … from substances or mixtures’ reaches is not stated; and waste is not a substance, mixture or article within the meaning of REACH article 3 (art. 2(2)).
Trap 3
Seveso III (Directive 2012/18/EU) lays down rules for the prevention of major accidents involving dangerous substances (art. 1). NIS2 article 4 disapplies NIS2 provisions only where a sector-specific Union act requires cybersecurity risk-management measures or incident notification at least equivalent in effect.
What else applies to you
Regulation (EC) No 1907/2006 (REACH), which defines the manufacturer, the distributor and the article the entry refers to (art. 3(3), (9) and (14)); Directive 2012/18/EU (Seveso III), for the prevention of major accidents involving dangerous substances. The CER annex has no chemicals row.
Article 4 disapplies a NIS2 provision only where a sector-specific Union act requires cybersecurity risk-management measures or incident notification at least equivalent in effect — and only for the entities that act covers.