Regulation, Standardisation and Certification

Do you know the difference between a national regulation, a European Union (EU) regulation, an EU directive, or a standard? Or how European regulations are passed into law? Do you know the difference between ISO and CEN? For those confused between compulsory and voluntary compliance, or how certification and standardisation work together, we have the article for you. Eurovent Certification is on hand to explain the background of regulation, standardisation and certification, the impact of European standards on the industry and the role of certification in providing transparent, verified product data to prove compliance.

Regulation

What is a regulation? 

A regulation is a rule or directive issued by a governing authority, such as a government, or regulatory agency such as the European Commission. Regulations are used to implement laws passed by legislatures, provide detailed guidance on how laws are to be applied, and establish requirements that individuals, organisations, or businesses must follow within a specific jurisdiction.

For countries within the European Union, there are several forms of regulation. These include:

National regulations: Laws, rules, and regulations enacted by individual EU member states. Each member state has its own legal system and authority to pass legislation within its borders. National regulations apply only within the territory of the respective member state. Therefore, these regulations may vary from one country to another within the EU.

EU regulations: Legally binding acts adopted by EU institutions (European Commission, European Parliament, Council of the European Union) that are directly applicable in all member states. EU regulations have immediate legal effect upon publication. They are designed to ensure consistency and harmonisation of laws across the EU, particularly in areas where uniformity is crucial, such as trade, competition, and consumer protection.

EU directives (New Approach Directives): Legislative acts issued by the EU that set out specific objectives to be achieved by member states. Directives do not have direct legal effect in member states upon publication. However, member states are required to incorporate directives into their national laws, within a specified timeframe. Therefore, member states have some flexibility in how they implement those objectives into their domestic legal systems. Directives are often used in areas where the EU seeks to harmonise laws or policies across member states, while also allowing for some adaptation to national circumstances.

When it comes to HVAC and refrigeration products sold in Europe, manufacturers must prove compliance with all relevant regulations to place products on the market. Products may be subject to national regulations, EU regulations, New Approach Directives, and some will also be subject to energy labelling requirements. Some regulations only require self-declaration, while others may require testing by a notified laboratory, independent of the manufacturer, or the intervention of a notified body for factory production control.

Regulations are enforced by government agencies responsible for monitoring compliance with regulations. You can find out more about the legislative context in chapter 2 of Eurovent’s Industry Recommendation for bidirectional residential ventilation units.

Standardisation

What is a standard?

A standard is a reference framework aimed at providing guidelines, and technical or qualitative requirements for products, services, or practices. Standards are created in service of the general interest and launched at the initiative of market participants.

Standards are based on the knowledge of experts in their chosen field, who are aware of the needs of the organisations they represent – whether they are manufacturers, distributors, buyers, users, trade associations, consumers, or regulators. Standards are essentially created by the industry and its stakeholders, as a result of consensual co-production and cooperation between the actors involved in its development. 

The majority of standards are voluntary, not compulsory. They go above and beyond the basic requirements as set out in regulations. Therefore, any organisation may or may not comply with the relevant standards, but those who do will be following best practice.

European standards

You will most commonly hear about ISO and CEN standards.

• ISO (International Organization for Standardization) covers international standards.
• CEN (European Committee for Standardisation) covers European standards.

The CEN contributes to the objectives set by the EU by developing voluntary technical standards, called European standards. They are aimed at promoting:

• International trade and competition
• The safety of workers and consumers
• The interoperability (synergy) of networks including post, railways, road networks, transport of energy, water and other resources, etc.
• Environmental protection
• Research and development programmes
• Conditions for access to markets and public funding.

A large number of so-called "harmonised" European standards also allow market participants to apply the European legislation to their products or services which they are subject to.

The European standards must be included identically in the collections of the national members of CEN, which disseminate them as national standards. In some cases, European standards are used within the framework of the New Approach Directives, which are accompanied by a standardisation mandate issued to CEN by the European Commission. These directives set out essential requirements that products must meet in order to be placed on the market. However, if a product is shown to comply with certain European standards (known as "harmonised standards"), it is automatically deemed to comply with the essential requirements contained in the directives in question. The harmonised standards are also cited in the OJEU, which indicates which directive each standard complies with.

This standard-based process avoids additional regulation and does not restrict technological innovation.

Certification

What is certification?

Certification tests and evaluates product performances. Third-party certification removes the risk of variations between stated and real product performance, via independently verified data. 
Certification programmes are developed by consensus with all stakeholders, who can then express their expectations and needs in the field/markets. Depending on the circumstances, certification can be voluntary or compulsory. 

Mandatory product certification is required by law for certain products. It ensures they meet the minimum requirements as set out in the relevant regulations, so they can be placed on the market. 

Voluntary product certification is not legally required but is pursued by manufacturers to demonstrate the quality, performance, or environmental attributes of their products. Voluntary certification differentiates products in the marketplace as going above and beyond the minimum regulatory requirements. There are a number of voluntary third-party certification schemes available, however, it should be noted that not all are equal. 

How are products Eurovent certified?

Did you know that 74% of HVAC and refrigeration products sold in Europe are Eurovent certified? Products that are tested by Eurovent are evaluated under a common set of criteria, based on European and international standards, (depending on the climate zone). All products go through a stringent, fair and identical certification process, wherever in the world they are manufactured.

Key to the Eurovent offering is that certification is voluntary and cannot be bought. Eurovent certified products must pass a number of checkpoints to receive certification. State-of-the-art evaluation protocols are utilised including:

• Independent laboratory tests
• Factory audits
• Selection software checks
• Product sampling issued from factory
• Product purchase on the market (when possible)
• Data consistency algorithms crossed by product family
• Plus, most products undergo yearly surveillance monitoring to ensure standards remain high.

Impartiality is embedded in the Eurovent certification process as manufacturers and laboratories have no direct contact, keeping the process clear of any bias. Additionally, tested products can be taken from the production line, factory stock or point of sale. The purpose of the sampling rules is to ensure that the products are representative.  

Eurovent’s comprehensive admission and follow-up evaluations (annual and ongoing) include testing in independent laboratories (ISO 17 025 accredited), audits (of production sites), software verifications, plus monitoring of communication media of participants, applicants, and non-licensee manufacturers to prevent misuse. 

These valuation operations aim to strengthen market confidence, particularly in the reliability of the data announced, and to reduce risk and the level of uncertainty. This enhances consumer confidence, as it proves compliance with more stringent EU / international standards. Eurovent certification finds the truth of a product, building trust between industry stakeholders.

Some of the additional benefits of certification include:

• Access to transparent, accurate, universally understood performance data, with internationally applied quality controls
• Certification data is freely accessible, up-to-date, and digitised via the free certified product directory
• Data can also be transferred/disseminated in different databases 
• The certification is issued by an independent and impartial third-party body, which allows products to be compared with identical rules and makes competition fair
• Certification maintains quality. Any drop in performance or quality will result in a change to certified data at best, or at worst removal of product certification
• Plus, Eurovent Certita Certification is an accredited certification body, recognised by Cofrac with accreditation number 5-0517. The scope of accreditation is available on www.cofrac.fr. This offers a guarantee of compliance with the established rules.

Conclusion

Standardisation sets best practice and synergies for goods, services, and processes, that can be replicated internationally, and in the case of CEN, throughout EU member states to enable trade in the single market. This enhances quality, safety, and reliability without having to implement heavy regulation. Likewise, certification creates a vigorous and impartial process to test and evaluate products to European standards. Therefore, industry professionals, buyers, end users and other industry stakeholders, can trust that certified products not only reach European standards, but all manufacturer claims also.

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