CE & Pi Marking

What is the difference between CE Marking and Pi (π) Marking?

CE Marking demonstrates that a product meets (minimally) all Essential Safety Requirements (ESR) of all European Directives that are applicable to the specific product. The CE Marking is an official mark within the scope of several European Directives (e.g. Pressure Equipment, Machinery, ATEX, Toys, Medical, etc. [EU Directives]).

The Pi (π) Marking is essentially the same as the CE Marking, however, it applies only to certain types of Transportable Pressure Equipment (TPED) (see Table below).

The following Guidance applies to both CE Marking and Pi (π) Marking: Guidance on CE Marking

European Certifications: CE and Pi [π] Marking Table

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General Information

ECE Global management consists of proven Design & Engineering professionals, as well as a ready access to an internationally recognized European Notification Body organization with a keen understanding of the importance of certification and the impact it can have on an organization. The applicability of codes, requirements, related procedures and the consequences thereof to your organization and clientele is one of our main considerations for all your certification needs.

Preventing the expense of costly unnecessary tasks, loss of additional profit, and creating an advantage for your competition are often related to not taking advantage of all allowed compliance strategies and requirements.

Products bearing the CE Marking (see Details of CE Marking) indicate their compliance with all essential provisions of the applicable directives necessary to obtain legislative CE Marking status, meaning the product has been subjected to a conformity assessment procedure provided for in the applicable directives.

ECE’s extensive experience in evaluating the applicability of European Directives, Codes & Requirements, as well as providing sound and suitable project and approvals plans, has saved many of our customers significant time and money and resulted in potential advantages over their competitors.

Together with your staff, either as project leaders or project engineers, we can implement the required procedures and work instructions needed for your operations. Our cohesive team approach has been demonstrated successful in numerous industrial applications and projects, resulting in the maximization of cost and time saving strategies.

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Please note: EU Directives are not applicable to all countries listed above.

Details Related to CE / Pi [π] Marking

Factors like globalization, increasing liabilities and more intense competition are considerations for each company in its every day business.

The European Union has implemented, and continues to implement, requirements for the harmonization of this unique single market. The task is to break down national certification requirements and to encourage the acceptance of products that fulfill European Directives (EU Legislative Requirements), and free movement of goods is a cornerstone of the single market. The mechanisms in place to achieve this aim are based on prevention of new barriers to trade, mutual recognition, and technical harmonization.

National technical regulations are subject to the provisions of Articles 28 and 30 of the Treaty establishing the European Community (the EC Treaty), which prohibit quantitative restrictions or measures having equivalent effect. Case law of the European Court of Justice, especially Case 120/78 (the ‘Cassis de Dijon’case), provides the key elements for mutual recognition. The effect of this case law is as follows:

• Products legally manufactured or marketed in one country should in principle move freely throughout the Community, where such products meet equivalent levels of protection to those imposed by the Member State of exportation, and where they are marketed in the territory of the exporting country.
• In the absence of Community measures, Member States are free to legislate in their territory.
• Barriers to trade, which result from differences between national legislation, may only be accepted, if national measures:
  • are necessary to satisfy mandatory requirements (such as health, safety, consumer protection, and environmental protection);
  • serve a legitimate purpose justifying the breach of the principle of free movement of goods; and
  • can be justified with regard to the legitimate purpose and are proportionate with the aims. Restrictions to free movement of products, which may be acceptable under Articles 28 and 30 of the EC Treaty, can only be avoided or eliminated through technical harmonization on a Community level. This harmonization was, at first, rather slow to implement for two reasons. First, the legislation became highly technical, as it had the objective of meeting the individual requirements of each product category. Second, the adoption of technical harmonization directives was based on unanimity in the Council.

The creation of a single market by December 31, 1992 could not have been achieved without a new regulatory technique that set down only the general essential requirements, reduced the control of public authorities prior to a product being placed on the market, and integrated quality assurance and other modern conformity assessment techniques.

Moreover, the decision-making procedure needed to be adapted in order to facilitate the adoption of technical harmonization directives by a qualified majority in the Council. A new regulatory technique and strategy was laid down by the Council Resolution of 1985 on the New Approach to technical harmonization and standardization, which established the following principles:

• Legislative harmonization is limited to essential requirements that products placed on the Community market must meet, if they are to benefit from free movement within the Community.
• The technical specifications of products meeting the essential requirements set out in the directives are laid down in harmonized standards.
• Application of harmonized or other standards remains voluntary, and the manufacturer may always apply other technical specifications to meet the requirements.
• Products manufactured in compliance with harmonized standards benefit from a presumption of conformity with the corresponding essential requirements.

The operation of the New Approach requires that the standards offer a guaranteed level of protection with regard to the essential requirements established by the directives, and that the national authorities carry out their responsibilities for the protection of safety or other interests covered by the directive. Further, a safeguard clause procedure is necessary to allow the possibility of contesting the conformity of a product, or failures or shortcomings of harmonized standards.

The New Approach entailed refining conformity assessment in such a way as to allow the Community legislator to evaluate the consequences of the utilization of different conformity assessment mechanisms. The objective was to provide flexibility of conformity assessment over the entire manufacturing process in order for it to be adapted to the needs of each individual operation.

The Global Approach introduced a modular approach, which subdivided conformity assessment into a number of operations (modules). These modules differ according to the stage of development of the product (for example design, prototype, full production), the type of assessment involved (for example documentary checks, type approval, quality assurance), and the person carrying out the assessment (the manufacturer or a third party).

The Global Approach was completed by Council Decision 90/683/EEC, which was replaced and brought up to date by Decision 93/465/EEC. These decisions lay down general guidelines and detailed procedures for conformity assessment that are to be used in New Approach directives.

Thus, conformity assessment is based on:

• Manufacturers’ internal design and production control activities;
• Third party type examination combined with manufacturers’ internal production control activities;
• Third party type or design examination combined with third party approval of product or production quality assurance systems, or third party product verification;
• Third party unit verification of design and production; or
• Third party approval of full quality assurance systems.

In addition to laying down guidelines for the use of conformity assessment procedures in technical harmonization directives, Decision 93/465/EEC harmonizes the rules for the affixing and use of the CE marking.

The legal basis for adopting or modifying New Approach directives is Article 95 of the EC Treaty.

According to Article 251 of the EC Treaty, the Commission initiates the legislative procedure by making a proposal to the Council and to the European Parliament. Such Commission proposals concerning health, safety, environmental protection, and consumer protection should, according to Article 95 take as a basis a high level of protection.

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