CELEX 02008R1272 · v20250901

TITLE IV / PACKAGING

TITLE IV

Article 35

Packaging

Packaging containing hazardous substances or mixtures shall satisfy the following requirements:

(a)

the packaging shall be designed and constructed so that its contents cannot escape, except in cases where other more specific safety devices are prescribed;

(b)

the materials constituting the packaging and fastenings shall not be susceptible to damage by the contents, or liable to form hazardous compounds with the contents;

(c)

the packaging and fastenings shall be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling;

(d)

packaging fitted with replaceable fastening devices shall be designed so that it can be refastened repeatedly without the contents escaping.

Packaging containing a hazardous substance or a mixture supplied to the general public shall not have either a shape or design likely to attract or arouse the active curiosity of children or to mislead consumers, or have a similar presentation or a design used for foodstuff or animal feeding stuff or medicinal or cosmetic products, which would mislead consumers.

Where the packaging contains a substance or mixture which meets the requirements in section 3.1.1 of Annex II it shall have a child-resistant fastening in accordance with sections 3.1.2, 3.1.3 and 3.1.4.2 of Annex II.

Where the packaging contains a substance or mixture which meets the requirements in section 3.2.1 of Annex II it shall bear a tactile warning of danger in accordance with section 3.2.2 of Annex II.

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Where a liquid consumer laundry detergent, as defined in Article 2(1a) of Regulation (EC) No 648/2004 of the European Parliament and of the Council ( 4 ), is contained in a soluble packaging for single use, the additional requirements of section 3.3 of Annex II shall apply.

▼B

The packaging of substances and mixtures shall be deemed to satisfy the requirements of paragraph 1(a), (b) and (c) if it complies with the requirements of the rules on the transport of dangerous goods by air, sea, road, rail or inland waterways.

Article 35

Packaging

Packaging containing hazardous substances or mixtures shall satisfy the following requirements:

(a)

the packaging shall be designed and constructed so that its contents cannot escape, except in cases where other more specific safety devices are prescribed;

(b)

the materials constituting the packaging and fastenings shall not be susceptible to damage by the contents, or liable to form hazardous compounds with the contents;

(c)

the packaging and fastenings shall be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling;

(d)

packaging fitted with replaceable fastening devices shall be designed so that it can be refastened repeatedly without the contents escaping.

Packaging containing hazardous substances or mixtures shall satisfy the following requirements:

(a)

the packaging shall be designed and constructed so that its contents cannot escape, except in cases where other more specific safety devices are prescribed;

(b)

the materials constituting the packaging and fastenings shall not be susceptible to damage by the contents, or liable to form hazardous compounds with the contents;

(c)

the packaging and fastenings shall be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling;

(d)

packaging fitted with replaceable fastening devices shall be designed so that it can be refastened repeatedly without the contents escaping.

Packaging containing hazardous substances or mixtures shall satisfy the following requirements:

(a)

the packaging shall be designed and constructed so that its contents cannot escape, except in cases where other more specific safety devices are prescribed;

(a)

the packaging shall be designed and constructed so that its contents cannot escape, except in cases where other more specific safety devices are prescribed;

(b)

the materials constituting the packaging and fastenings shall not be susceptible to damage by the contents, or liable to form hazardous compounds with the contents;

(b)

the materials constituting the packaging and fastenings shall not be susceptible to damage by the contents, or liable to form hazardous compounds with the contents;

(c)

the packaging and fastenings shall be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling;

(c)

the packaging and fastenings shall be strong and solid throughout to ensure that they will not loosen and will safely meet the normal stresses and strains of handling;

(d)

packaging fitted with replaceable fastening devices shall be designed so that it can be refastened repeatedly without the contents escaping.

(d)

packaging fitted with replaceable fastening devices shall be designed so that it can be refastened repeatedly without the contents escaping.

Where the packaging contains a substance or mixture which meets the requirements in section 3.2.1 of Annex II it shall bear a tactile warning of danger in accordance with section 3.2.2 of Annex II.

▼M10 ▼M10

▼B ▼B

TITLE V

CHAPTER 1

Article 36

Harmonisation of classification and labelling of substances

A substance that fulfils the criteria set out in Annex I for the following shall normally be subject to harmonised classification and labelling in accordance with Article 37:

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(a)

respiratory sensitisation, category 1, 1A or 1B (Annex I, section 3.4);

▼B

(b)

germ cell mutagenicity, category 1A, 1B or 2 (Annex I, section 3.5);

(c)

carcinogenicity, category 1A, 1B or 2 (Annex I, section 3.6);

(d)

reproductive toxicity, category 1A, 1B or 2 (Annex I, section 3.7);

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(e)

endocrine disruption for human health, category 1 or 2 (Annex I, section 3.11);

(f)

endocrine disruption for the environment, category 1 or 2 (Annex I, section 4.2);

(g)

persistent, bioaccumulative and toxic (Annex I, section 4.3);

(h)

very persistent, very bioaccumulative (Annex I, section 4.3);

(i)

persistent, mobile and toxic (Annex I, section 4.4);

(j)

very persistent, very mobile (Annex I, section 4.4).

▼M36

Substances that are active substances falling within the scope of Regulation (EC) No 1107/2009 or Regulation (EU) No 528/2012 shall be subject to harmonised classification and labelling. For such substances, the procedures set out in Article 37(1), (4), (5) and (6) shall apply.

▼B

Where a substance fulfils the criteria for other hazard classes or differentiations than those referred to in paragraph 1 and does not fall under paragraph 2, a harmonised classification and labelling in accordance with Article 37 may also be added to Annex VI on a case-by-case basis, if justification is provided demonstrating the need for such action at Community level.

Article 37

Procedure for harmonisation of classification and labelling of substances

▼M36

A competent authority may submit to the Agency a proposal for harmonised classification and labelling of a substance or a group of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for a revision thereof.

The Commission may request the Agency or the European Food Safety Authority (the ‘Authority’) established in accordance with Article 1(2) of Regulation (EC) No 178/2002 to prepare a proposal for harmonised classification and labelling of a substance or a group of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, or a proposal for revision thereof. The Commission may subsequently submit the proposal to the Agency.

The proposals for harmonised classification and labelling of a substance or a group of substances referred to in the first and the second subparagraphs shall follow the format set out in Part 2 of Annex VI and contain the relevant information provided for in Part 1 of Annex VI.

▼M36

1a.

Whenever considered scientifically justified and possible by a competent authority or the Commission, proposals for harmonised classification and labelling shall aim to prioritise groups of substances rather than individual substances.

1b.

The Agency and the Authority may, on their own initiative, provide scientific advice to the competent authorities and the Commission indicating that a harmonised classification and labelling of a substance or a group of substances would be appropriate.

▼M36

Manufacturers, importers and downstream users may submit to the Agency a proposal for harmonised classification and labelling of substances and, where appropriate, specific concentration limits, M-factors or acute toxicity estimates, provided that there is no entry in Part 3 of Annex VI for such substances in relation to the hazard class or differentiation covered by that proposal.

▼B

The proposal shall be drawn up in accordance with the relevant Parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006 and it shall follow the format set out in Part B of the Chemical Safety Report of section 7 of that Annex. It shall contain the relevant information provided for in Part 1 of Annex VI to this Regulation. Article 111 of Regulation (EC) No 1907/2006 shall apply.

▼M36

2a.

Before submitting a proposal to the Agency, a competent authority, manufacturer, importer or downstream user shall notify the Agency of its intention to submit a proposal for harmonised classification and labelling.

Where the Commission has requested the preparation of a proposal pursuant to paragraph 1, second subparagraph, it shall notify the Agency of that request.

Within one week of receipt of the notification referred to in the first and the second subparagraphs, the Agency shall publish the name and, where relevant, the EC and CAS numbers of the substance or substances, the status of the proposal and the name of the submitter. The Agency shall update the information on the status of the proposal after completion of each stage of the process referred to in paragraphs (4) and (5).

Where a competent authority receives a proposal in accordance with paragraph 6, it shall notify the Agency and provide any relevant information on its reason for accepting or refusing the proposal. The Agency shall share that information with the other competent authorities.

▼M36

Where the proposal of the manufacturer, importer or downstream user concerns the harmonised classification and labelling of substances in accordance with Article 36(3), it shall be accompanied by the fee determined by the Commission by means of implementing act adopted in accordance with the examination procedure referred to in Article 54(2).

▼B

The Committee for Risk Assessment of the Agency set up pursuant to Article 76(1)(c) of Regulation (EC) No 1907/2006 shall adopt an opinion on any proposal submitted pursuant to paragraphs 1 or 2 within 18 months of receipt of the proposal, giving the parties concerned the opportunity to comment. The Agency shall forward this opinion and any comments to the Commission.

▼M36

Where the Commission finds that the harmonisation of the classification and labelling of the substance concerned is appropriate, it shall adopt without undue delay, and preferably before the end of the calendar year following the publication of the opinion of the Committee for Risk Assessment, delegated acts in accordance with Article 53a to amend Annex VI by including substances together with the relevant classification and label elements and, where appropriate, the specific concentration limits, M-factors or acute toxicity estimates in Table 3 of Part 3 of Annex VI.

Where, in the case of harmonisation of classification and labelling of substances, imperative grounds of urgency so require, the procedure provided for in Article 53b shall apply to delegated acts adopted pursuant to this paragraph.

Manufacturers, importers and downstream users who have new information which may lead to a change of the harmonised classification and labelling of substances in Part 3 of Annex VI shall submit a proposal in accordance with paragraph 2, second subparagraph, to the competent authority in one of the Member States in which the substances are placed on the market.

▼M36

In order to avoid duplication of assessment of hazardous properties of substances, the Commission is empowered to adopt delegated acts in accordance with Article 53a to amend Table 3 of Part 3 of Annex VI to this Regulation to:

(a)

include substances by 11 June 2026 as endocrine disruption for human health category 1, as endocrine disruption for the environment category 1, as persistent, bioaccumulative and toxic, or as very persistent, very bioaccumulative, together with relevant classification and label elements on the basis of respective criteria where by 11 June 2025, those substances:

(i)

have been included in the candidate list referred to in Article 59(1) of Regulation (EC) No 1907/2006 as having endocrine-disrupting properties for human health or the environment, as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative,

(ii)

have been identified as having endocrine-disrupting properties in accordance with section 3.6.5 or section 3.8.2 of Annex II to Regulation (EC) No 1107/2009, or as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative in accordance with section 3.7.2 or 3.7.3 of Annex II to that Regulation and a decision on the application for approval or the renewal of approval of those substances has been adopted under that Regulation;

(iii)

have been identified as having endocrine-disrupting properties in accordance with Article 1 of Delegated Regulation (EU) 2017/2100, or as persistent, bioaccumulative and toxic or as very persistent and very bioaccumulative in accordance with Article 5(1), point (e), of Regulation (EU) No 528/2012 and a decision on the application for approval or renewal of approval of those substances has been adopted under Regulation (EU) No 528/2012; and

(b)

include substances in Table 3 of Part 3 of Annex VI as endocrine disruption for human health category 1, as endocrine disruption for the environment category 1, as persistent, bioaccumulative and toxic, or as very persistent, very bioaccumulative, together with relevant classification and label elements on the basis of the respective criteria where:

(i)

those substances have been included in the candidate list referred to in Article 59 of Regulation (EC) No 1907/2006 before 11 June 2026 as having one of the properties mentioned in the introductory part and for which a dossier as provided for in Annex XV to that Regulation was under assessment by 11 June 2025;

(ii)

a decision on the application for approval or the renewal of approval of those substances identified as having one of the properties mentioned in the introductory part has been adopted under Regulation (EC) No 1107/2009 before 11 June 2032 and an application for approval or renewal of approval of those substances in accordance with the relevant provisions of that Regulation was submitted before 11 June 2025;

(iii)

—

the evaluating competent authority has submitted its draft assessment report on the application for approval or renewal of approval to the Agency in accordance with the relevant provisions of Regulation (EU) No 528/2012;

—

the application was submitted for the purposes of Directive 98/8/EC and the Member State evaluation in accordance with that Directive was completed by 1 September 2013, but no decision on the application for approval or renewal of approval was adopted before that date; or

—

the Agency has submitted to the Commission an opinion pursuant to Article 75(1), point (g), of Regulation (EU) No 528/2012 following a request to establish whether the respective criteria are met.

In the case of a proposal for harmonised classification and labelling of a group of substances, those substances shall be grouped together on the basis of clear scientific reasoning taking into account how the available information supports the grouping of substances and allows the property or properties of the substance or substances to be reliably predicted from information on other substances in the group.

▼B

Article 38

Content of opinions and decisions for harmonised classification and labelling in Part 3 of Annex VI; accessibility of information

Any opinion referred to in Article 37(4) and any decision according to Article 37(5) shall at least specify for each substance:

(a)

the identity of the substance as specified in sections 2.1 to 2.3.4 of Annex VI to Regulation (EC) No 1907/2006;

(b)

the classification of the substance referred to in Article 36, including a statement of reasons;

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(c)

the specific concentration limits, M-factors or acute toxicity estimates, where applicable;

▼B

(d)

the label elements specified in points (d), (e) and (f) of Article 17(1) for the substance, together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1);

(e)

any other parameter enabling an assessment to be made of the health or environmental hazard of mixtures containing the hazardous substance in question or of substances containing such hazardous substances as identified impurities, additives and constituents, if relevant.

When making publicly available an opinion or a decision as referred to in Article 37(4) and (5) of this Regulation, Article 118(2) and Article 119 of Regulation (EC) No 1907/2006 shall apply.

CHAPTER 2

Article 39

Scope

This Chapter shall apply to:

(a)

substances subject to registration in accordance with Regulation (EC) No 1907/2006;

(b)

substances within the scope of Article 1 which meet the criteria for classification as hazardous and are placed on the market either on their own or in a mixture above the concentration limits specified in this Regulation or Directive 1999/45/EC, where relevant, which results in the classification of the mixture as hazardous.

Article 40

Obligation to notify the Agency

Any manufacturer or importer, or group of manufacturers or importers (hereinafter referred to as ‘the notifier(s)’), who places on the market a substance referred to in Article 39, shall notify to the Agency the following information in order for it to be included in the inventory referred to in Article 42:

(a)

the identity of the notifier(s) responsible for placing the substance or substances on the market as specified in section 1 of Annex VI to Regulation (EC) No 1907/2006;

(b)

the identity of the substance or substances as specified in section 2.1 to 2.3.4 to Annex VI to Regulation (EC) No 1907/2006;

(c)

the classification of the substance or substances in accordance with Article 13;

(d)

where a substance has been classified in some but not all hazard classes or differentiations, an indication of whether this is due to lack of data, inconclusive data, or data which are conclusive although insufficient for classification;

(e)

specific concentration limits or M-factors, where applicable, in accordance with Article 10 of this Regulation together with a justification using the relevant Parts of sections 1, 2 and 3 of Annex I to Regulation (EC) No 1907/2006;

(f)

the label elements specified in points (d), (e) and (f) of Article 17(1) for the substance or substances together with any supplemental hazard statements for the substance, determined in accordance with Article 25(1).

The information referred to in (a) to (f) shall not be notified, if it has been submitted to the Agency as part of a registration pursuant to Regulation (EC) No 1907/2006, or if it has already been notified by that notifier.

The notifier shall submit this information in the format specified pursuant to Article 111 of Regulation (EC) No 1907/2006.

The information listed in paragraph 1 shall be updated and notified to the Agency by the notifier(s) concerned when, pursuant to the review in Article 15(1), a decision to change the classification and labelling of the substance has been taken.

Substances placed on the market on or after 1 December 2010 shall be notified in accordance with paragraph 1 within one month after their placing on the market.

However, substances placed on the market before 1 December 2010 may be notified in accordance with paragraph 1 before that date.

Article 41

Agreed entries

Where the notification in Article 40(1) results in different entries on the inventory referred to in Article 42 for the same substance, the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory. The notifiers shall inform the Agency accordingly.

Article 42

The classification and labelling inventory

The Agency shall establish and maintain a classification and labelling inventory in the form of a database.

The information notified pursuant to Article 40(1) shall be included in the inventory, as well as information submitted as part of registrations under Regulation (EC) No 1907/2006.

Information in the inventory which corresponds to the information referred to in Article 119(1) of Regulation (EC) No 1907/2006 shall be publicly accessible. The Agency shall grant access to the other information on each substance in the inventory to the notifiers and registrants who have submitted information on that substance in accordance with Article 29(1) of Regulation (EC) No 1907/2006. It shall grant access to such information to other parties subject to Article 118 of that Regulation.

The Agency shall update the inventory when it receives updated information in accordance with Article 40(2) or Article 41.

In addition to the information referred to in paragraph 1, the Agency shall, where applicable, include the following information in each entry:

(a)

whether, in respect of the entry, there is harmonised classification and labelling at Community level by inclusion in Part 3 of Annex VI;

(b)

whether, in respect of the entry, it is a joint entry between registrants of the same substance as referred to in Article 11(1) of Regulation (EC) No 1907/2006;

(c)

whether it is an agreed entry of two or more notifiers or registrants in accordance with Article 41;

(d)

whether the entry differs from another entry on the inventory for the same substance.

The information referred to in (a) shall be updated where a decision is taken in accordance with Article 37(5).

ARTICLE 35 / Packaging

Source: Content sourced from EUR-Lex and licensed under CC BY 4.0. This is an unofficial presentation; only the official EUR-Lex version is legally authentic.

TITLE IV / PACKAGING

TITLE IV

Article 35

Article 35

TITLE V

CHAPTER 1

Article 36

Article 37

Article 38

CHAPTER 2

Article 39

Article 40

Article 41

Article 42

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