The essentials

The NIS2 dossier lists the eighteen sectors. For a manufacturer, the question is settled at a finer level: the exact nature of what it makes.

The industrial activities named in the annexes

Industrial activities covered by the annexes of the NIS2 Directive and the criterion used
ActivityAnnexCriterion used by the directive
Computer, electronic and optical productsIINACE Rev. 2, division 26
Electrical equipmentIINACE Rev. 2, division 27
Machinery and equipment not elsewhere classifiedIINACE Rev. 2, division 28
Motor vehicles, trailers and semi-trailersIINACE Rev. 2, division 29
Other transport equipmentIINACE Rev. 2, division 30
Medical devices and in vitro diagnostic medical devicesIIManufacturers within the meaning of Regulations (EU) 2017/745 and 2017/746
ChemicalsIIManufacture of substances, distribution of substances or mixtures, production of articles from substances or mixtures, within the meaning of the REACH Regulation
FoodIIIndustrial production and processing, wholesale distribution
Basic pharmaceutical products and pharmaceutical preparationsI (health)NACE Rev. 2, division 21
Medical devices considered critical during a public health emergencyI (health)List drawn up under Regulation (EU) 2022/123

The French NAF rév. 2 classification takes over the NACE divisions: the first two digits of a company’s APE code give the division.

Three points of reading

The activity carried out, not just the activity code

For divisions 26 to 30, the directive covers undertakings “carrying out any of the economic activities” of the division. It does not say this must be the principal activity, whereas it does so for waste management. The APE code, assigned according to the principal activity, therefore gives a first indication; a secondary manufacturing activity deserves to be examined.

The “chemicals” line is broader than its heading

It also covers the production of articles from substances or mixtures, within the meaning of REACH. A materials processor checks this point before concluding.

Metalworking is not on the list

Division 25, the manufacture of fabricated metal products, general mechanical engineering included, appears in neither annex. A machining workshop therefore has no direct obligation on that basis. The manufacture of parts and accessories for motor vehicles, by contrast, falls under division 29.

Essential or important: what changes for a manufacturer

Annex II activities fall into the category of important entities, including for a large enterprise. A machinery manufacturer with 2,000 employees is an important entity. A pharmaceutical company of the same size, covered by Annex I, is an essential entity. The State can also designate an entity whose interruption would have particular consequences.

Four manufacturers’ cases

Reading of four manufacturers’ situations under the NIS2 Directive
SituationReading
Packaging equipment manufacturer, 180 employeesDivision 28 and medium size: important entity.
General engineering workshop, 70 employees, subcontractor to several manufacturersDivision 25, absent from the annexes: no direct obligation. Its customers in scope will send it their security requirements.
Food manufacturer, 300 employeesIndustrial food processing, Annex II: important entity, including for a large enterprise.
Group of three companies: a holding company, an electric motor plant with 140 employees, a trading company with 30 employeesQualification is done company by company. The plant falls under division 27: important entity. The trading company does not carry out a listed activity, even though the group’s headcount is added together to calculate its size.

The size calculation within a group is detailed on the page NIS2 and SMEs.

Are production systems in scope?

Yes. Article 21 covers the network and information systems the entity uses “for their operations”. It does not separate business IT from industrial IT: controllers, supervision, shop-floor management and remote maintenance access are to be protected wherever production depends on them. The same article takes an “all-hazards approach”, which includes the physical environment of those systems.

The questions to ask on a production site

  • Which lines stop if the ERP, the supervision system or the plant network goes down, and how long do they hold in degraded mode?
  • Who accesses the machines remotely: manufacturers, integrators, maintenance providers? With which accounts and what trace?
  • Do backups cover controller programs, recipes and machine parameters? Have they been restored?
  • Which equipment no longer receives patches, and how is it isolated?
  • Would an incident on a line reach management fast enough to meet the 24-hour early warning deadline?

IKNSA’s approach for industry starts from these dependencies between production, supply chain and site infrastructure.

Frequently asked questions

Our APE code starts with 28: are we in scope?
If the company reaches medium size, yes in principle, as an important entity. The conclusion is confirmed on the activity actually carried out and on the size calculation, group included.
We make parts for a car manufacturer: are we in scope?
It depends on how your activity is classified. The manufacture of parts and accessories for motor vehicles falls under division 29, covered by Annex II. Contract metalworking falls under division 25, which is not. In both cases, the car manufacturer will ask you for security assurances by contract.
Does a group present in several countries answer to a single authority?
No. Each company falls under the Member State where it is established. A German subsidiary follows the German transposition law, a French subsidiary the French one.
Does a maker of connected products fall under NIS2 or the Cyber Resilience Act?
The two texts do not have the same object. NIS2 addresses the entity and its own information systems. The Cyber Resilience Act deals with the product placed on the market. A manufacturer of electronic equipment can fall under both; see the Cyber Resilience Act note.

Check your situation

The guided NIS2 assessment reviews the entity, the sector, the size, governance, suppliers and incidents. It takes about six minutes and returns a first reading of applicability. If you supply a manufacturer in scope, see NIS2 for suppliers and subcontractors.

Choose the NIS2 assessment Discuss your NIS2 scope