Decree Law No. 111-D/2017
- Issuer: Economy
- Diploma Type: Decree Law
- Number: 111-D/2017
- Pages: 5250-(2076) a 5250-(2116)
Summary in plain english
What is it?
This decree-law introduces into the Portuguese law the European directive 2014/68/EU on the availability of pressure equipment on the market.
Pressure equipment is equipment intended to contain a liquid, gas or vapour at a pressure higher than that of air — for example, containers, piping, safety accessories and pressure fittings.
The equipment is considered to be available on the market when it is put into distribution or used on the European Union market in a commercial activity, which may or may not involve a payment.
What will change?
New rules will be defined for the design, manufacture and conformity assessment of pressure equipment and assemblies subject to a maximum pressure of more than 0.5 bar that are put on sale in Portugal:
- new and produced by a manufacturer established in a Member State of the European Union
- new or second-hand, imported from outside the European Union.
In order to be made available on the market and put into service, the equipment must:
- comply with the requirements set out in this decree-law
- receive maintenance
- be used for the purpose for which it was created.
Safety requirements for equipment are defined in the annexes of the decree-law.
Responsibilities of economic operators
The economic operators who must comply with these safety rules are:
- manufacturers of equipment and protective systems
- agents — people or companies — representing the manufacturers within the European Union
- importers of such equipment and systems
- distributors of such equipment and systems.
Manufacturers have a responsibility to ensure that all products they offer or use comply with the European safety rules set out in this regulation. For this, they must:
- have the products evaluated to ensure they comply with European safety rules
- prove that the products comply with European safety rules by attaching an "EU declaration of conformity" (or another declaration in the case of parts) and label them with CE marking
- provide instructions and safety information with each product, in Portuguese and written in plain language
- withdraw any products from the market if there is any suspicion that they may not comply with some of the safety rules and recall those that have already been sold.
Agents have a responsibility to carry out the tasks that manufacturers instruct them to do on their behalf. They must:
- provide all information necessary proving that products comply with the rules (including declarations of conformity and the product’s technical documents) to the Authority for Economic and Food Safety (ASAE)
- collaborate with the ASAE to eliminate risks that products may pose.
Importers and distributors have a responsibility to only place products on the market that comply with the European safety rules set out in this regulation. They must make sure that the manufacturer has fulfilled all of its responsibilities regarding the products concerned. In addition, they must:
- immediately inform the manufacturer and the ASAE if they suspect that a product presents a risk
- ensure that the storage and transportation conditions do not compromise compliance with safety rules
- withdraw any products from the market if there is any suspicion that they may not comply with some of the safety rules and recall those that have already been sold
- collaborate with the ASAE to eliminate risks that products may pose.
Pressure equipment is classified into four different classes according to the hazard they represent. These classes fall into two groups. Substances or mixtures that may represent physical or health hazard belong to group 1.
European approval of materials
Approval of materials to be used in pressure equipment may be requested by one or more manufacturers of materials or equipment. Approval will be made by an appointed entity, accredited by the Portuguese Institute of Accreditation (IPAC).
The appointed entity has to make the necessary examinations and tests to prove that the materials fulfil the requirements defined in this decree-law.
This process takes at least three months.
Entity accreditation and notification
Assessing compliance with safety rules is carried out by entities that belong to companies or professional associations related to the products they evaluate. To ensure their impartiality, they must be independent from the organizations and products they evaluate.
To be able to carry out its activity, an evaluator must obtain in the following order:
- the accreditation (legal recognition) from the Portuguese Institute of Accreditation (IPAC)
- the notification (authorization) from the Portuguese Institute of Quality (IPQ), which informs the European Commission of its intention to be an evaluator.
To obtain the notification after being accredited by IPAC, an entity must file a request for notification by completing an online form at the Entrepreneur's Desk (Balcão do Empreendedor).
Entities may only begin their activities if there is no objection from the European Commission or from Member States within two weeks of the request for notification.
The procedures for evaluating whether a product complies with the safety rules are defined in the annexes of this law and depend on the type of product.
EU Declaration of Conformity
This declaration indicates that a device or protective system to be used in potentially explosive atmospheres meets the safety requirements of this decree-law. This declaration must:
- comply with the template provided in Annex X of this Decree-Law
- contain the information specified in Annexes III to IX of this Decree-Law
- be written in Portuguese
- be up to date.
The CE marking must be displayed on the products:
- visible place where it cannot be deleted
- before placing the equipment on the market.
The marking may also be displayed on the equipment's identification plate — or the packaging and accompanying documents if it cannot be placed on the product or on the identification plate.
The CE marking indicates that a product complies with the laws in the European Union and can move freely on the European market. When using CE marking on a product, the manufacturer is declaring that they have taken the responsibility of ensuring the product meets all the CE mark requirements.
This decree-law requires the application of European market monitoring rules to ensure that products harmful to the health or safety of users are prohibited.
The Authority for Economic and Food Safety (ASAE) is responsible for overseeing the application of the rules defined in this decree-law. ASAE may request the help of other entities when necessary.
The Tax and Customs Authority oversees border control of equipment coming from countries outside the European Union.
Those who do not comply with these rules may have to pay fines of:
- 250 euros to 3,500 euros, for individuals
- 2,500 euros to 40,000 euros, for companies.
IPQ is the authority responsible for monitoring the application of this decree-law and proposing necessary measures to achieve its goals.
What are its benefits?
This decree-law is intended to adapt Portuguese law to the European rules on the availability of pressure equipment on the market.
This aims to ensure that:
- pressure equipment does not endanger the health or safety of people, domestic animals and property
- everyone involved in putting this equipment on the market knows and fulfils their obligations.
When does it come into effect?
This decree-law comes into effect the day after being published.
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