Notification Detail

Regulation which lays down the conditions of the Approval Scheme in Portugal for products in contact with water intended for human consumption.

Notification Number: 2015/234/P (Portugal)
Date received: 30/04/2015
End of Standstill: Closed

Issue of detailed opinion by: Commission
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Message 002

Communication from the Commission - TRIS/(2015) 01306
Directive 98/34/EC
Translation of the message 001
Notification: 2015/0234/P

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Nao inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 201501306.EN)

1. Structured Information Line
MSG 002 IND 2015 0234 P EN 30-04-2015 P NOTIF

2. Member State

3. Department Responsible
Ministério da Economia
Instituto Português da Qualidade
Rua António Gião, 2
2829-513 Caparica
Telefone: + 351 21 294 81 00
Fax: + 351 21 294 82 23

3. Originating Department
Entidade Reguladora dos Serviços de Águas e Resíduos (ERSAR) – Entidade Administrativa Independente
Centro Empresarial Torres de Lisboa - Rua Tomás da Fonseca, Torre G - 8º
1600-209 Lisboa
Telefone: + 351 210 052 200
Fax: + 351 210 052 259

4. Notification Number
2015/0234/P - C00C

5. Title
Regulation which lays down the conditions of the Approval Scheme in Portugal for products in contact with water intended for human consumption.

6. Products Concerned
Products and materials used in contact with water for human consumption from source to tap; chemical products used in the treatment of water intended for human consumption.

7. Notification Under Another Act

8. Main Content
The draft Regulation which lays down the Approval Scheme in Portugal aims to comply with Article 10 of Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption. The Regulation contains 29 Articles which lay down the product application and approval rules and five Annexes which set out the technical specifications of the conformity assessment of the product. With regard to the Annexes, 4 of the 5 relate to the evaluation of the effects of the product on water quality, by type of material covered by the Approval Scheme for Portugal: those made of organic materials, cementitious materials, metallic materials, and chemical products for water treatment. The fifth Annex contains the positive lists of substances already accepted for the chemical formulation of the product. The Approval Scheme for Portugal, for the majority of products, is based on a product certification process, which includes product testing and an audit of the manufacturing process. However, it is foreseen that products considered low risk can be approved without the audit phase of the manufacturing process and without intervention of the certification body. In either case, products are submitted to an evaluation of the toxicological conformity of their chemical formulation, to define the migration tests to be carried out on the product to assess the effects of the material on water quality. The Approval Scheme for Portugal, at the request of an economic operator, provides for the mutual recognition of a product approved by another Member State.

Key words: product, conformity, water intended for human consumption, certification, approval, mutual recognition.

9. Brief Statement of Grounds
The draft Regulation itself introduces a Statement of Reasons on the decision to set up the Approval Scheme for Portugal.
The drafting of the Regulation complies with Article 10 of Council Directive 98/83/EC of 3 November 1998, transposed into national law by Article 21 of Decree-Law No 306/2007 of 27 August 2007, which in paragraph 3 thereof provides that the ‘The competent authority (ERSAR) shall promote the establishment of a national approval scheme for the substances and chemicals used in the treatment of water and for the materials in contact with water for human consumption’.
In addition to the protection of human health, the Approval Scheme for Portugal aims to support the managing bodies in the selection of safe products, through the consultation of a list of approved products published on the ERSAR website, as it has proven difficult for the former to select products that have proven to be safe, with regard in particular to the collection and evaluation of the documentation submitted by suppliers.

10. Reference Documents - Basic Texts
Reference(s) to basic text(s): Decree-Law No 306/2007 of 27 August 2007, regulating quality of water for human consumption, revising and repealing Decree-Law No 243/2001 of 5 September 2001, which transposed Council Directive 98/83/EC of 3 November 1998 into national law.

11. Invocation of the Emergency Procedure

12. Grounds for the Emergency

13. Confidentiality

14. Fiscal measures

15. Impact assessment

16. TBT and SPS aspects
TBT aspect

No - the draft has no significant impact on international trade.

SPS aspect

No - the draft has no significant impact on international trade.

European Commission

Contact point Directive 98/34
Fax: +32 229 98043

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