Procedure for dealing with packaging presenting a risk at national level
1. Without prejudice to Article 19 of Regulation (EU) 2019/1020, where the market surveillance authorities of a Member State have sufficient reason to believe that packaging covered by this Regulation presents a risk to the environment or human health, they shall, without undue delay, carry out an evaluation in relation to the packaging concerned covering all requirements laid down in this Regulation that are relevant to that risk. The relevant economic operators shall cooperate as necessary with the market surveillance authorities.
For the purposes of the first subparagraph, the authorities responsible for the enforcement of this Regulation shall follow up on complaints or reports related to alleged non-compliance of packaging with this Regulation, and verify that the appropriate corrective action has been taken.
Where, in the course of the evaluation carried out pursuant to the first subparagraph, the market surveillance authorities find that the packaging does not comply with the requirements laid down in this Regulation, they shall, without delay, require the relevant economic operator to take appropriate and proportionate corrective measures, within a period prescribed by the market surveillance authorities which is reasonable and commensurate with the nature and, where relevant, the degree of the non-compliance, to bring the packaging into compliance with those requirements.
2. By way of derogation from paragraph 1, where there is a risk to human health relating to contact-sensitive packaging that is subject to a specific law aimed at protecting human health and that risk is transferred to the packaged content of the packaging material, the market surveillance authorities shall not carry out an evaluation in relation to the risk to human or animal health originating from the packaging material. Instead, they shall alert the authorities competent for evaluating such risks, namely the competent authorities referred to in Regulations (EU) 2017/625, (EU) 2017/745, (EU) 2017/746 or (EU) 2019/6 or Directive 2001/83/EC.
3. Where the market surveillance authorities consider that non-compliance is not restricted to their territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.
4. The economic operator shall ensure that all appropriate corrective measures are taken in respect of all the non-compliant packaging that the economic operator has made available on the market throughout the Union.
5. Where the economic operator does not take adequate corrective measures within the period referred to in paragraph 1, third subparagraph, or the non-compliance persists, the market surveillance authorities shall take all appropriate provisional measures to prohibit the making available of the packaging on their territory, to withdraw it or to recall it.
The market surveillance authorities shall inform the Commission and the other Member States of those measures without delay.
6. The information to be sent to the Commission and the other Member States pursuant to paragraph 5 of this Article shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 and shall include all available details, in particular the data necessary for the identification of the non-compliant packaging, the origin of the packaging, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the economic operator and, where applicable, the information referred to in Article 61(1) of this Regulation. The market surveillance authorities shall also indicate whether the non-compliance is due to either of the following:
(a)
failure of the packaging to meet the sustainability requirements laid down in or pursuant to this Regulation;
(b)
shortcomings in the harmonised standards or common specifications referred to in Articles 36 and 37 of this Regulation.
7. Member States other than the Member State taking the measures pursuant to paragraph 5 shall, without delay, inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the packaging concerned, and, in the event that Member States object to the measures taken pursuant to paragraph 5, of their objections.
8. Where, within 3months of receipt of the information referred to in paragraph 5 or 7 no objection has been raised either by a Member State or the Commission in respect of provisional measures taken by a Member State, those measures shall be considered justified.
Member States may provide for a longer or shorter period of application for provisional measures than 3months in order to take account of the specificities of the requirements concerned.
9. Member States shall ensure that the packaging is withdrawn from their market or that other appropriate restrictive measures are taken without delay in respect of the packaging or the manufacturer concerned.
Union safeguard procedure
1. Where, on completion of the procedure set out in Article 58(5) and (6), objections are raised against a measure taken by a Member State pursuant to Article 58, or where the Commission considers a national measure to be contrary to Union law, the Commission shall, without delay, enter into consultation with the Member States and the relevant economic operator and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified.
That implementing act shall be adopted in accordance with the examination procedure referred to in Article 65(2).
2. The Commission shall address the implementing act referred to in paragraph 1 to all Member States and shall communicate it to them and the relevant economic operator without delay.
If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant packaging is withdrawn from their market, and shall inform the Commission accordingly.
If the national measure is considered unjustified, the Member State concerned shall withdraw that measure.
3. Where the national measure is considered justified and the non-compliance of the packaging is attributed to shortcomings in the harmonised standards referred to in Article 36 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
4. Where the national measure is considered justified and the non-compliance of the packaging is attributed to shortcomings in the common technical specifications referred to in Article 37, the Commission shall, without delay, amend or repeal the common technical specifications concerned.
Compliant packaging which presents a risk
1. Where, having carried out an evaluation under Article 58, a Member State finds that although packaging is in compliance with the applicable requirements laid down in or pursuant to Articles 5 to 12, it nevertheless presents a risk to the environment or human health, it shall, without delay, require the relevant economic operator to:
(a)
take all appropriate measures, within a reasonable period prescribed by the market surveillance authorities and commensurate with the nature and, where relevant, the degree of risk, to ensure that the packaging concerned, when placed on the market, no longer presents that risk;
(b)
bring the packaging into conformity;
(c)
withdraw the packaging from the market; or
(d)
recall the packaging.
2. By way of derogation from paragraph 1, where there is a risk to human health relating to contact-sensitive packaging that is subject to a specific law aimed at protecting human health and that risk is transferred to the packaged content of the packaging material, the surveillance authorities shall not carry out an evaluation in relation to the risk to human or animal health originating from the packaging material. Instead, they shall alert the authorities competent for controlling such risks, namely the competent authorities referred to in Regulations (EU) 2017/625, (EU) 2017/745, (EU) 2017/746 or (EU) 2019/6 or Directive 2001/83/EC.
3. The economic operator shall ensure that corrective measures are taken in respect of all the non-compliant packaging that the economic operator has made available on the market throughout the Union.
4. The Member State shall immediately inform the Commission and the other Member States of its findings and subsequent actions pursuant to paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the non-compliant packaging, the origin and the supply chain of the packaging, the nature of the risk involved and the nature and duration of the national measures taken.
5. The Commission shall, without delay, enter into consultation with the Member State and the relevant economic operator and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified and, where necessary, propose appropriate measures.
That implementing act shall be adopted in accordance with the examination procedure referred to in Article 65(2).
On duly justified imperative grounds of urgency relating to the protection of the environment or human health, the Commission shall adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 65(3).
The Commission shall address the implementing act referred to in this paragraph to all Member States and shall immediately communicate it to them and the relevant economic operator.
Controls on packaging entering the Union market
1. Market surveillance authorities shall, without delay, communicate to the authorities designated pursuant to Article 25(1) of Regulation (EU) 2019/1020 the measures referred to in Article 58(5) of this Regulation where the non-compliance is not restricted to their territory. That communication shall include all relevant information, in particular the details necessary for the identification of the non-compliant packaging to which the measures apply and, in the case of a packaged product, the product itself.
2. The authorities designated pursuant to Article 25(1) of Regulation (EU) 2019/1020 shall use the information communicated pursuant to paragraph 1 of this Article for carrying out their risk analysis under Article 25(3) of Regulation (EU) 2019/1020.
3. The communication of information referred to in paragraph 1 shall take place through entering the information in the relevant customs risk management environment.
4. The Commission shall develop an interconnection to automate the communication referred to in paragraph 1 of this Article from the information and communication system referred to in Article 58(6) to the environment referred to in paragraph 3 of this Article. That interconnection shall start operating no later than 24 months from the date of the adoption of the implementing act referred to in paragraph 5 of this Article.
5. The Commission is empowered to adopt implementing acts specifying the procedural rules and the details of the implementation arrangements for paragraph 4 including the functionalities, data elements and data processing, as well as the rules on the processing of personal data, confidentiality and controllership for the interconnection referred to in paragraph 4.
Those implementing acts shall be adopted in accordance with the examination procedure pursuant to Article 65(2).
Formal non-compliance
1. Where a Member State becomes aware of any of the following circumstances, it shall require the relevant economic operator to put an end to the non-compliance concerned:
(a)
the EU declaration of conformity has not been drawn up;
(b)
the EU declaration of conformity has not been drawn up correctly;
(c)
the QR code or data carrier referred to in Article 12 do not provide access to the information required in accordance with that Article;
(d)
the technical documentation referred to in Annex VII is not available, is not complete or contains errors;
(e)
the information referred to in Article 15(6) or Article 18(3) is absent, false or incomplete;
(f)
any other administrative requirement set out in Article 15 or Article 18 is not fulfilled;
(g)
the requirements on restrictions on excessive packaging or on uses of certain packaging formats set out in Articles 24 and 25 are not complied with;
(h)
in relation to reusable packaging, the requirements on the establishment, operation or participation in a re-use system referred to in Article 27 are not fulfilled;
(i)
in relation to refill, the information requirements set out in Article 28(1) and (2) are not fulfilled;
(j)
the requirements on the refill stations set out in Article 28(3) are not fulfilled;
(k)
the re-use targets set out in Article 29 are not achieved;
(l)
the refill obligations in Article 32 and re-use offer obligation in Article 33 are not fulfilled;
(m)
the requirements on recyclable packaging set out in Article 6 are not fulfilled;
(n)
the requirements on minimum recycled content in plastic packaging set out in Article 7 are not fulfilled.
2. Where the non-compliance referred to in paragraph 1, points (a) to (f), persists, the Member State concerned shall take all appropriate measures to prohibit the packaging from being made available on the market or to ensure that the packaging is recalled or withdrawn from the market.
3. Where the non-compliance referred to in paragraph 1, points (g) to (n), of this Article persists, Member States shall apply the rules on penalties applicable to infringements of this Regulation which are laid down by the Member States in accordance with Article 68.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
