Attention New Jersey Exporters of Machinery to the European Union,

The European Union is in the process of revising one of their bellwether CE mark regulations, the Machine Products Regulation. The EU recently notified this regulation to the WTO (November 24, 2021) and is accepting comments from outside stakeholders such as U.S. exporters until February 22, 2022.

There are several reasons for this notice for review and action. First, the New Jersey business community should be aware of the fact that the EU is revising its Machine Regulation (formerly called the Machine Safety Directive), which is probably the regulation with the widest effect on U.S. exporters.

The area of greatest concern about this regulation is in Annex I (which is the old annex IV having to do with dangerous machines that cannot be self-certified). There are two new additions to the list of dangerous machines in Annex I, #24 software ensuring safety functions, including AI (artificial intelligence) systems; and, #25 machinery embedding AI systems ensuring safety functions. Some trade associations have advised that their companies have been using AI for a long time and to make these machines go through a type approval process (ie, lab testing) to get the CE mark would be cost prohibitive. We will be trying to either eliminate these two points from the list of dangerous machines or limit their scope.

We are hoping after you get back from the holiday break, you can become aware of coming changes in the Machine Products Regulation (which will probably be adopted in a one year); and 2) U.S. companies can make comments on the proposed regulation to the WTO by February 22, 2022.

In order to send comments to the WTO, a company would write up the comments and email their comments to:

European Commission,
EU-TBT Enquiry Point,
Fax: + (32) 2 299 80 43,
E-mail: grow-eu-tbt@ec.europa.eu

Please email a copy of your comments to U.S. Enquiry at NIST: usatbtep@nist.gov. A U.S. Enquiry Point Representative will relay the comments to the EU.

The EU notified this regulation on November 24, 2021 and will give companies 90 days to make comments. This is an ideal time for U.S. companies to make comments on this regulation. These regulations can, as we know, have an effect on trade.

For more information: Click here: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021PC0202&qid=1637865023492

Click to access 21_7349_00_e.pdf

Click to access 21_7349_01_e.pdf

To contact WTO: http://ec.europa.eu/growth/tools-databases/tbt/en/

WTO’s Official Notification:
The following notification is being circulated in accordance with Article 10.6

1. Notifying Member: EUROPEAN UNION
If applicable, name of local government involved (Article 3.2 and 7.2):

2. Agency responsible: European Commission
Name and address (including telephone and fax numbers, email and website addresses, if available) of agency or authority designated to handle comments regarding the notification shall be indicated if different from above:
European Commission,
EU-TBT Enquiry Point,
Fax: +(32) 2 299 80 43,
E-mail: grow-eu-tbt@ec.europa.eu
Website: http://ec.europa.eu/growth/tools-databases/tbt/en/

3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [X], 5.7.1 [ ], other:

4. Products covered (HS or CCCN where applicable, otherwise national tariff heading. ICS numbers may be provided in addition, where applicable): Safety of machinery (ICS 13.110)

5. Title, number of pages and language(s) of the notified document: Proposal for a Regulation of the European Parliament and of the Council on machinery products (COM(2021) 202 final) (55 page(s), in English; 67 page(s), in English)

6. Description of content: This proposal for a Regulation takes into account the result of the evaluation of the machinery Directive 2006/42/EC.
Following the recommendations highlighted during the evaluation the proposal covers:
• Clarity on the scope, exclusions and some definitions, including a new definition on “substantial modification” when the machine suffers a substantial modification, without the manufacturers agreement once is placed on the market.
• New risks originating from digitalised machinery. In particular those originated from a direct human-robot collaboration, connected machinery, software updates that affects the behaviour of the machinery after its placing on the market, as well as the ability of manufacturers to conduct a full risk assessment on machine learning applications before the product is placed on the market. As far as the autonomous machines, the Regulation explicitly considers the possibility of no driver, and sets up requirements.
• Clarifications on a number of requirements on “traditional machinery” related to installation of lifting appliances, slow speed lifts, seating, protection against hazardous substances, overhead power lines and vibration from portable handheld and hand guided machinery
• Criteria to define high risk machinery and the possibility to adapt the current list of high-risk machinery to the state of the art as well as a mandatory third-party conformity assessment for this type of machinery.
• Digitalisation of the machinery instructions and the manufacturers declaration of conformity with the possibility to request paper instructions at the time of buying the machinery product.
• Alignment to Decision 768/2008/EC to bring together all the elements required for a comprehensive regulatory framework to operate effectively for the safety and compliance of machinery products.

7. Objective and rationale, including the nature of urgent problems where applicable: The main objective is the protection of health and safety of persons and, where appropriate, domestic animals or plants and property and, where applicable, the environment. Based on the evaluation of the Machinery Directive 2006/42/EC, new generation of digitalised machinery products, e.g. internet connected machinery or machinery with learning capacities, may entail new risks for the health and safety of persons, domestic animals and property and the environment. Furthermore, clarifying some of the existing provisions in Directive 2006/42/EC will contribute to the main objective too. Protection of human health or safety; Protection of animal or plant life or health; Protection of the environment

8. Relevant documents: Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast); OJ L 157, 9.6.2006, p. 24–86
EUR-Lex – 32006L0042 – EN – EUR-Lex (europa.eu)

9. Proposed date of adoption: 2-3 years from now
Proposed date of entry into force: 20 days after its publication (transitional period of 30 months until full application foreseen)

10. Final date for comments: 90 days from notification

11. Texts available from: National enquiry point [ ] or address, telephone and fax numbers and email and website addresses, if available, of other body:
European Commission,
EU-TBT Enquiry Point,
Fax: + (32) 2 299 80 43,
E-mail: grow-eu-tbt@ec.europa.eu

The text is available on the EU-TBT Website : http://ec.europa.eu/growth/tools-databases/tbt/en/
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52021PC0202&qid=1637865023492

Click to access 21_7349_00_e.pdf

Click to access 21_7349_01_e.pdf