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Article 41

Common Specifications

Updated on May 21st 2024 based on the version and article numbering approved by the EU Parliament on May 14th 2024.

1. The Commission may adopt, implementing acts establishing common specifications for the requirements set out in Section 2 of this Chapter or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V where the following conditions have been fulfilled:

  1. the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the requirements set out in Section 2 of this Chapter, or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V, and:
    (i) the request has not been accepted by any of the European standardisation organisations; or
    (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or
    (iii) the relevant harmonised standards insufficiently address fundamental rights concerns; or
    (iv) the harmonised standards do not comply with the request; and
  2. no reference to harmonised standards covering the requirements referred to in Section 2 of this Chapter or, as applicable, the obligations referred to in Sections 2 and 3 of Chapter V has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012, and no such reference is expected to be published within a reasonable period.

When drafting the common specifications, the Commission shall consult the advisory forum referred to in Article 67.

The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 98(2).

2. Before preparing a draft implementing act, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers the conditions laid down in paragraph 1 of this Article to be fulfilled.

3. High-risk AI systems or general-purpose AI models which are in conformity with the common specifications referred to in paragraph 1, or parts of those specifications, shall be presumed to be in conformity with the requirements set out in Section 2of this Chapter or, as applicable, to comply with the obligations referred to in Sections 2 and 3 of Chapter V, to the extent those common specifications cover those requirements or those obligations.

4. Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the publication of its reference in the Official Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. When reference to a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 1, or parts thereof which cover the same requirements set out in Section 2 of this Chapter or, as applicable, the same obligations set out in Sections 2 and 3 of Chapter V.

5. Where providers of high-risk AI systems or general-purpose AI models do not comply with the common specifications referred to in paragraph 1, they shall duly justify that they have adopted technical solutions that meet the requirements referred to in Section 2 of this Chapter or, as applicable, comply with the obligations set out in Sections 2 and 3 of Chapter V to a level at least equivalent thereto.

6. Where a Member State considers that a common specification does not entirely meet the requirements set out in Section 2 or, as applicable, comply with obligations set out in Sections 2 and 3 of Chapter V, it shall inform the Commission thereof with a detailed explanation. The Commission shall assess that information and, if appropriate, amend the implementing act establishing the common specification concerned.

[Previous version]

Updated on May 8th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19th 2024.

1. The Commission may adopt, implementing acts establishing common specifications for the requirements set out in Section 2 of this Chapter or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V where the following conditions have been fulfilled:

  1. the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the requirements set out in Section 2 of this Chapter, or, as applicable, for the obligations set out in Sections 2 and 3 of Chapter V, and:
    (i) the request has not been accepted by any of the European standardisation organisations; or
    (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or
    (iii) the relevant harmonised standards insufficiently address fundamental rights concerns; or
    (iv) the harmonised standards do not comply with the request; and
  2. no reference to harmonised standards covering the requirements referred to in Section 2 of this Chapter or, as applicable, the obligations referred to in Sections 2 and 3 of Chapter V has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012, and no such reference is expected to be published within a reasonable period.

When drafting the common specifications, the Commission shall consult the advisory forum referred to in Article 67.

The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 98(2).

2. Before preparing a draft implementing act, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers the conditions laid down in paragraph 1 of this Article to be fulfilled.

3. High-risk AI systems or general-purpose AI models which are in conformity with the common specifications referred to in paragraph 1, or parts of those specifications, shall be presumed to be in conformity with the requirements set out in Section 2of this Chapter or, as applicable, to comply with the obligations referred to in Sections 2 and 3 of Chapter V, to the extent those common specifications cover those requirements or those obligations.

4. Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the publication of its reference in the Official Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. When reference to a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 1, or parts thereof which cover the same requirements set out in Section 2 of this Chapter or, as applicable, the same obligations set out in Sections 2 and 3 of Chapter V.

5. Where providers of high-risk AI systems or general-purpose AI models do not comply with the common specifications referred to in paragraph 1, they shall duly justify that they have adopted technical solutions that meet the requirements referred to in Section 2 of this Chapter or, as applicable, comply with the obligations set out in Sections 2 and 3 of Chapter V to a level at least equivalent thereto.

6. Where a Member State considers that a common specification does not entirely meet the requirements set out in Section 2 or, as applicable, comply with obligations set out in Sections 2 and 3 of Chapter V, it shall inform the Commission thereof with a detailed explanation. The Commission shall assess that information and, if appropriate, amend the implementing act establishing the common specification concerned.

Updated on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.

1. The Commission is empowered to adopt, implementing acts establishing common specifications for the requirements set out in Section 2 of this Chapter or, as applicable, for the obligations set out in Chapter IV where the following conditions have been fulfilled:

  1. the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the requirements set out in Section 2 of this Chapter, and:
    (i) the request has not been accepted by any of the European standardisation organisations; or
    (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or
    (iii) the relevant harmonised standards insufficiently address fundamental rights concerns; or
    (iv) the harmonised standards do not comply with the request; and

  2. no reference to harmonised standards covering the requirements referred to in Section 2 of this Title has been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012, and no such reference is expected to be published within a reasonable period.

    The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 98(2), after consulting the advisory forum referred to in Article 67.

2. Before preparing a draft implementing act, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers the conditions laid down in paragraph 1 of this Article to be fulfilled.

3. High-risk AI systems which are in conformity with the common specifications referred to in paragraph 1, or parts of those specifications, shall be presumed to be in conformity with the requirements set out in Section 2, to the extent those common specifications cover those requirements.

4. Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the publication of its reference in the Official Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. When reference to a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal the implementing acts referred to in paragraph 1, or parts thereof which cover the same requirements set out in Section 2 of this Chapter.

5. Where providers of high-risk AI systems do not comply with the common specifications referred to in paragraph 1, they shall duly justify that they have adopted technical solutions that meet the requirements referred to in Section 2 to a level at least equivalent thereto.

6. Where a Member State considers that a common specification does not entirely meet the requirements set out in Section 2, it shall inform the Commission thereof with a detailed explanation. The Commission shall assess that information and, if appropriate, amend the implementing act establishing the common specification concerned.

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