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1. Member States shall take the measures necessary to ensure that any producer responsibility organisation established under Article 9(3):

(a) has a clearly defined geographical coverage that is consistent with the requirements set out in Article 8;

(b) has the financial and organisational means necessary to meet the extended producer responsibility obligations of the producers, including financial guarantees to ensure the continuity of the quaternary treatment of urban wastewater in accordance with Article 8 in all circumstances;

(c) makes publicly available information about:

(i) its ownership and membership;

(ii) the financial contributions paid by producers in line with the requirements referred to in Article 9(3), second subparagraph, point (c);

(iii) the activities that it undertakes every year, including clear information on how its financial means are used.

Member States shall ensure that such measures include a national recognition procedure certifying the compliance of the producer responsibility organisations with the requirements set out in this paragraph prior to their effective establishment and operation. The provision of information to the public under this Article shall be without prejudice to preserving the confidentiality of business information in accordance with relevant Union and national law.

2. Member States shall establish an adequate monitoring and enforcement framework to ensure that producer responsibility organisations fulfil their obligations in a transparent manner, that the financial means of producer responsibility organisations are properly used and that all actors having extended producer responsibility report reliable data to the competent authorities and, when requested, to the producer responsibility organisations.

3. Where, in the territory of a Member State, there are multiple producer responsibility organisations, the Member State concerned shall appoint at least one body independent of private interests or entrust a public authority to oversee the implementation of Article 9.

4. A Member State shall ensure that the producers established on the territory of another Member State or in a third country, and placing products on that Member State’s market:

(a) appoint a legal or natural person established on its territory as an authorised representative for the purpose of fulfilling the extended producer responsibility obligations on its territory; or (b) take measures equivalent to point (a).

5. To ensure that the extended producer responsibility system is implemented as optimally as possible, in particular from a cost-benefit perspective, Member States shall organise regular dialogues on its implementation. This may include support for identifying measures to be taken by the competent authorities to inter alia:

(a) reduce micropollutant pressure at source, and (b) determine the most appropriate technologies for quaternary treatment.

Member States shall ensure that those dialogues involve relevant stakeholders and, where relevant, associations of stakeholders involved in the implementation of extended producer responsibility, including producers and distributors, producer responsibility organisations, private or public operators of urban wastewater treatment plants, local authorities and civil society organisations.

6. By 1 January 2025, the Commission shall provide for the organisation of exchange of information, experience and best practices between Member States on the implementation of Article 9 and this Article and in particular on:

(a) the measures to control the establishment, the recognition and functioning of producer responsibility organisations;

(b) the measures to control the compliance of producers with their obligations defined in this Directive;

(c) the effective implementation of:

(i) the coverage of the costs as referred to in Article 9(1), and (ii) the controls on the methods of calculation of producers’ contributions by the producer responsibility organisation as referred to in Article 9(3), point (c);

(d) the exemptions provided for in Article 9(2);

(e) any other issue in relation to the effective implementation of Article 9 and this Article;

(f) the possible impacts of the application of the requirements referred to in Article 9 on the accessibility, availability and affordability of medicines placed on the Union market.

The Commission shall publish the results of the exchange of information, experience and best practices on those and other relevant aspects and, where relevant, provide recommendations or guidelines, or both, to Member States.

7. On the basis of the information provided by Member States, the Commission shall establish and regularly update a list of the requests for exemption received by Member States from producers under Article 9(2). That list shall be made available on request to the competent authorities of the Member States.