Part 3 / SPECIAL RULES ON PACKAGING

PART 3: SPECIAL RULES ON PACKAGING

3.1.   Provisions relating to child-resistant fastenings

Provisions relating to child-resistant fastenings

3.1.1.   Packaging to be fitted with child-resistant fastenings

Packaging to be fitted with child-resistant fastenings

3.1.1.1. Packaging of whatever capacity containing a substance or mixture supplied to the general public and classified for acute toxicity, categories 1 to 3, STOT — single exposure category 1, STOT — repeated exposure category 1, or skin corrosion category 1 shall be fitted with child-resistant fastenings.

3.1.1.1. Packaging of whatever capacity containing a substance or mixture supplied to the general public and classified for acute toxicity, categories 1 to 3, STOT — single exposure category 1, STOT — repeated exposure category 1, or skin corrosion category 1 shall be fitted with child-resistant fastenings.  

3.1.1.2. Packaging of whatever capacity containing a substance or mixture supplied to the general public presenting an aspiration hazard and classified according to sections 3.10.2 and 3.10.3 of Annex I and labelled according to section 3.10.4.1 of Annex I, with the exception of substances and mixtures placed on the market in the form of aerosols or in a container fitted with a sealed spray attachment, shall be fitted with child-resistant fastenings.

3.1.1.2. Packaging of whatever capacity containing a substance or mixture supplied to the general public presenting an aspiration hazard and classified according to sections 3.10.2 and 3.10.3 of Annex I and labelled according to section 3.10.4.1 of Annex I, with the exception of substances and mixtures placed on the market in the form of aerosols or in a container fitted with a sealed spray attachment, shall be fitted with child-resistant fastenings.  

3.1.1.3 Where a substances or mixture has at least one of the substances mentioned below present in a concentration equal to or greater than the maximum individual concentrations specified, which are supplied to the general public, the packaging of whatever capacity shall be fitted with child-resistant fastenings.

3.1.1.3 Where a substances or mixture has at least one of the substances mentioned below present in a concentration equal to or greater than the maximum individual concentrations specified, which are supplied to the general public, the packaging of whatever capacity shall be fitted with child-resistant fastenings.  

No

Identification of the substance

Concentration limit

CAS No

Name

EC No

1

67-56-1

methanol

200-659-6

≥ 3 %

2

75-09-2

dichloromethane

200-838-9

≥ 1 %

No

Identification of the substance

Concentration limit

CAS No

Name

EC No

1

67-56-1

methanol

200-659-6

≥ 3 %

2

75-09-2

dichloromethane

200-838-9

≥ 1 %

No

Identification of the substance

Concentration limit

CAS No

Name

EC No

1

67-56-1

methanol

200-659-6

≥ 3 %

2

75-09-2

dichloromethane

200-838-9

≥ 1 %

No

Identification of the substance

Concentration limit

No

No

Identification of the substance

Identification of the substance

Concentration limit

Concentration limit

CAS No

Name

EC No

CAS No

CAS No

Name

Name

EC No

EC No

1

67-56-1

methanol

200-659-6

≥ 3 %

1

1

67-56-1

67-56-1

methanol

methanol

200-659-6

200-659-6

≥ 3 %

≥ 3 %

2

75-09-2

dichloromethane

200-838-9

≥ 1 %

2

2

75-09-2

75-09-2

dichloromethane

dichloromethane

200-838-9

200-838-9

≥ 1 %

≥ 1 %

3.1.2   Reclosable packages

Reclosable packages

Child-resistant fastenings used on reclosable packages shall comply with EN ISO standard 8317 as amended relating to ‘Child-resistant packages — Requirements and methods of testing for reclosable packages’ adopted by the European Committee for standardisation (CEN) and the International Standard Organisation (ISO).

3.1.3   Non-reclosable packages

Non-reclosable packages

Child-resistant fastenings used on non-reclosable packages shall comply with CEN standard EN 862 as amended relating to ‘Packaging — Child-resistant packaging — Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products’ adopted by the European Committee for Standardisation (CEN).

3.1.4   Notes

Notes

3.1.4.1. Evidence of conformity with the above standards may be certified only by laboratories which conform with Standard EN ISO/IEC 17025 as amended.

3.1.4.1. Evidence of conformity with the above standards may be certified only by laboratories which conform with Standard EN ISO/IEC 17025 as amended.  

3.1.4.2.   Specific cases Specific cases

If it seems obvious that packaging is sufficiently safe for children because they cannot get access to the contents without the help of a tool, the test referred to in section 3.1.2 or 3.1.3 does not need to be performed.

In all other cases and when there are sufficient grounds for doubting the security of the closure for a child, the national authority may ask the person responsible for putting the product on the market to give it a certificate from a certifying laboratory, referred to in section 3.1.4.1, stating that either:

— 
the type of closure is such that it is not necessary to perform the test referred to in section 3.1.2. or 3.1.3; or
— 
— 
the type of closure is such that it is not necessary to perform the test referred to in section 3.1.2. or 3.1.3; or
the type of closure is such that it is not necessary to perform the test referred to in section 3.1.2. or 3.1.3; or
— 
the closure has been tested and has been found to conform with the standards referred to above.
— 
— 
the closure has been tested and has been found to conform with the standards referred to above.
the closure has been tested and has been found to conform with the standards referred to above.

▼M4 ▼M4

3.2    Tactile Warnings

Tactile Warnings Tactile Warnings

3.2.1.    Packaging to be fitted with a tactile warning

Packaging to be fitted with a tactile warning Packaging to be fitted with a tactile warning Packaging to be fitted with a tactile warning

3.2.1.1. Where substances or mixtures are supplied to the general public and classified for acute toxicity, skin corrosion, germ cell mutagenicity category 2, carcinogenicity category 2, reproductive toxicity category 2, respiratory sensitisation, STOT categories 1 or 2, aspiration hazard, flammable gases, flammable liquids categories 1 or 2, or flammable solids, the packaging of whatever capacity, shall be fitted with a tactile warning of danger.

3.2.1.1. Where substances or mixtures are supplied to the general public and classified for acute toxicity, skin corrosion, germ cell mutagenicity category 2, carcinogenicity category 2, reproductive toxicity category 2, respiratory sensitisation, STOT categories 1 or 2, aspiration hazard, flammable gases, flammable liquids categories 1 or 2, or flammable solids, the packaging of whatever capacity, shall be fitted with a tactile warning of danger.  

3.2.1.2. Section 3.2.1.1 does not apply to transportable gas receptacles. Aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard need not be fitted with a tactile warning unless they are classified for one or more of the other hazards in section 3.2.1.1.

3.2.1.2. Section 3.2.1.1 does not apply to transportable gas receptacles. Aerosols and containers fitted with a sealed spray attachment and containing substances or mixtures classified as presenting an aspiration hazard need not be fitted with a tactile warning unless they are classified for one or more of the other hazards in section 3.2.1.1.  

3.2.2.    Provisions relating to tactile warning

Provisions relating to tactile warning Provisions relating to tactile warning Provisions relating to tactile warning

The technical specifications for tactile warning devices shall conform to EN ISO standard 11683 as amended ‘Packaging — Tactile warnings of danger — Requirements’.

▼M10 ▼M10

3.3    Liquid consumer laundry detergents in soluble packaging for single use

Liquid consumer laundry detergents in soluble packaging for single use Liquid consumer laundry detergents in soluble packaging for single use

Where a liquid consumer laundry detergent in dosages for single use is contained in a soluble packaging, the following additional provisions shall apply:

3.3.1. 

Liquid consumer laundry detergents contained in soluble packaging for single use shall be contained in an outer packaging. The outer packaging shall fulfil the requirements of section 3.3.2 and the soluble packaging shall fulfil the requirements of section 3.3.3.

3.3.1. 
3.3.1. 

Liquid consumer laundry detergents contained in soluble packaging for single use shall be contained in an outer packaging. The outer packaging shall fulfil the requirements of section 3.3.2 and the soluble packaging shall fulfil the requirements of section 3.3.3.

Liquid consumer laundry detergents contained in soluble packaging for single use shall be contained in an outer packaging. The outer packaging shall fulfil the requirements of section 3.3.2 and the soluble packaging shall fulfil the requirements of section 3.3.3.

3.3.2. 

The outer packaging shall:

(i) 

be opaque or obscure so that it impedes the visibility of the product or individual doses;

(ii) 

without prejudice to Article 32(3), bear the precautionary statement P102 ‘Keep out of reach of children’ at a visible place and in a format that attracts attention;

(iii) 

be an easily reclosable, self-standing container;

(iv) 

without prejudice to the requirements of section 3.1, be fitted with a closure that:

(a) 

impedes the ability of young children to open the packaging by requiring coordinated action of both hands with a strength that makes it difficult for young children to open it;

(b) 

maintains its functionality under conditions of repeated opening and closing for the entire life span of the outer packaging.

3.3.2. 
3.3.2. 

The outer packaging shall:

(i) 

be opaque or obscure so that it impedes the visibility of the product or individual doses;

(ii) 

without prejudice to Article 32(3), bear the precautionary statement P102 ‘Keep out of reach of children’ at a visible place and in a format that attracts attention;

(iii) 

be an easily reclosable, self-standing container;

(iv) 

without prejudice to the requirements of section 3.1, be fitted with a closure that:

(a) 

impedes the ability of young children to open the packaging by requiring coordinated action of both hands with a strength that makes it difficult for young children to open it;

(b) 

maintains its functionality under conditions of repeated opening and closing for the entire life span of the outer packaging.

The outer packaging shall:

(i) 

be opaque or obscure so that it impedes the visibility of the product or individual doses;

(i) 
(i) 

be opaque or obscure so that it impedes the visibility of the product or individual doses;

be opaque or obscure so that it impedes the visibility of the product or individual doses;

(ii) 

without prejudice to Article 32(3), bear the precautionary statement P102 ‘Keep out of reach of children’ at a visible place and in a format that attracts attention;

(ii) 
(ii) 

without prejudice to Article 32(3), bear the precautionary statement P102 ‘Keep out of reach of children’ at a visible place and in a format that attracts attention;

without prejudice to Article 32(3), bear the precautionary statement P102 ‘Keep out of reach of children’ at a visible place and in a format that attracts attention;

(iii) 

be an easily reclosable, self-standing container;

(iii) 
(iii) 

be an easily reclosable, self-standing container;

be an easily reclosable, self-standing container;

(iv) 

without prejudice to the requirements of section 3.1, be fitted with a closure that:

(a) 

impedes the ability of young children to open the packaging by requiring coordinated action of both hands with a strength that makes it difficult for young children to open it;

(b) 

maintains its functionality under conditions of repeated opening and closing for the entire life span of the outer packaging.

(iv) 
(iv) 

without prejudice to the requirements of section 3.1, be fitted with a closure that:

(a) 

impedes the ability of young children to open the packaging by requiring coordinated action of both hands with a strength that makes it difficult for young children to open it;

(b) 

maintains its functionality under conditions of repeated opening and closing for the entire life span of the outer packaging.

without prejudice to the requirements of section 3.1, be fitted with a closure that:

(a) 

impedes the ability of young children to open the packaging by requiring coordinated action of both hands with a strength that makes it difficult for young children to open it;

(a) 
(a) 

impedes the ability of young children to open the packaging by requiring coordinated action of both hands with a strength that makes it difficult for young children to open it;

impedes the ability of young children to open the packaging by requiring coordinated action of both hands with a strength that makes it difficult for young children to open it;

(b) 

maintains its functionality under conditions of repeated opening and closing for the entire life span of the outer packaging.

(b) 
(b) 

maintains its functionality under conditions of repeated opening and closing for the entire life span of the outer packaging.

maintains its functionality under conditions of repeated opening and closing for the entire life span of the outer packaging.

3.3.3. 

The soluble packaging shall:

(i) 

contain an aversive agent in a concentration which is safe, and which elicits oral repulsive behaviour within a maximum time of 6 seconds, in case of accidental oral exposure;

(ii) 

retain its liquid content for at least 30 seconds when the soluble packaging is placed in water at 20 °C;

(iii) 

resist mechanical compressive strength of at least 300 N under standard test conditions.

3.3.3. 
3.3.3. 

The soluble packaging shall:

(i) 

contain an aversive agent in a concentration which is safe, and which elicits oral repulsive behaviour within a maximum time of 6 seconds, in case of accidental oral exposure;

(ii) 

retain its liquid content for at least 30 seconds when the soluble packaging is placed in water at 20 °C;

(iii) 

resist mechanical compressive strength of at least 300 N under standard test conditions.

The soluble packaging shall:

(i) 

contain an aversive agent in a concentration which is safe, and which elicits oral repulsive behaviour within a maximum time of 6 seconds, in case of accidental oral exposure;

(i) 
(i) 

contain an aversive agent in a concentration which is safe, and which elicits oral repulsive behaviour within a maximum time of 6 seconds, in case of accidental oral exposure;

contain an aversive agent in a concentration which is safe, and which elicits oral repulsive behaviour within a maximum time of 6 seconds, in case of accidental oral exposure;

(ii) 

retain its liquid content for at least 30 seconds when the soluble packaging is placed in water at 20 °C;

(ii) 
(ii) 

retain its liquid content for at least 30 seconds when the soluble packaging is placed in water at 20 °C;

retain its liquid content for at least 30 seconds when the soluble packaging is placed in water at 20 °C;

(iii) 

resist mechanical compressive strength of at least 300 N under standard test conditions.

(iii) 
(iii) 

resist mechanical compressive strength of at least 300 N under standard test conditions.

resist mechanical compressive strength of at least 300 N under standard test conditions.

▼B ▼B

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