Chapter II – Safety requirements (Art. 5-8)

Economic operators shall place or make available on the market only safe products.

1. When assessing whether a product is a safe product, the following aspects in particular shall be taken into account:
   1. the characteristics of the product, including its design, technical features, composition, packaging, instructions for assembly and, where applicable, for installation, use and maintenance;
   2. the effect on other products, where it is reasonably foreseeable that the product will be used with other products, including the interconnection of those products;
   3. the effect that other products might have on the product to be assessed, where it is reasonably foreseeable that other products will be used with that product, including the effect of non-embedded items that are meant to determine, change or complete the way the product to be assessed works, which has to be taken into consideration when assessing the safety of the product to be assessed;
   4. the presentation of the product, the labelling, including the labelling regarding age suitability for children, any warnings and instructions for its safe use and disposal, and any other indication or information regarding the product;
   5. the categories of consumers using the product, in particular by assessing the risk for vulnerable consumers such as children, older people and persons with disabilities, as well as the impact of gender differences on health and safety;
   6. the appearance of the product where it is likely to lead consumers to use the product in a way different to what it was designed for, and in particular:
      1. where a product, although not foodstuff, resembles foodstuff and is likely to be confused with foodstuff due to its form, odour, colour, appearance, packaging, labelling, volume, size or other characteristics and might therefore be placed in the mouth, sucked or ingested by consumers, especially by children;
      2. where a product, although neither designed nor intended for use by children, is likely to be used by children or resembles an object commonly recognised as appealing to or intended for use by children because of its design, packaging or characteristics;
   7. when required by the nature of the product, the appropriate cybersecurity features necessary to protect the product against external influences, including malicious third parties, where such an influence might have an impact on the safety of the product, including the possible loss of interconnection;
   8. when required by the nature of the product, the evolving, learning and predictive functionalities of the product.
2. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk shall not constitute grounds for considering a product to be a dangerous product.

1. For the purpose of this Regulation, a product shall be presumed to be in conformity with the general safety requirement laid down in Article 5 of this Regulation in the following cases:
   1. it conforms to relevant European standards or parts thereof as far as the risks and risk categories covered by those standards are concerned, the references of which have been published in the Official Journal of the European Union in accordance with Article 10(7) of Regulation (EU) No 1025/2012; or
   2. in the absence of any relevant European standards as referred to in point (a) of this paragraph, the product conforms to national requirements, as regards the risks and risk categories covered by health and safety requirements laid down in the national law of the Member State in which it is made available on the market, provided that such law is in compliance with Union law.
2. The Commission shall adopt implementing acts determining the specific safety requirements to be covered by European standards in order to ensure that products which conform to those European standards satisfy the general safety requirement laid down in Article 5. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 46(3).
3. However, the presumption of conformity with the general safety requirement under paragraph 1 shall not prevent market surveillance authorities from taking all appropriate measures under this Regulation where there is evidence that, despite such presumption, the product is dangerous.

1. For the purpose of Article 6 and where the presumption of safety under Article 7 does not apply, when assessing whether a product is safe, the following elements in particular shall be taken into account, when available:
   1. European standards other than those the references of which have been published in the Official Journal of the European Union in accordance with Article 10(7) of Regulation (EU) No 1025/2012;
   2. international standards;
   3. international agreements;
   4. voluntary certification schemes or similar third-party conformity assessment frameworks, in particular those conceived to support Union law;
   5. Commission recommendations or guidelines on product safety assessment;
   6. national standards drawn up in the Member State in which the product is made available;
   7. the state of the art and technology, including the opinion of recognised scientific bodies and expert committees;
   8. product safety codes of good practice in force in the sector concerned;
   9. reasonable consumer expectations concerning safety;
   10. safety requirements adopted in accordance with Article 7(2).