The mission of NORMAPME is to represent the interests of all European Small and Medium Sized Enterprises in the European standardisation processes. Consultations of SMEs (on general standardisation policy or to more sector-specific issues) are essential for the realisation of this objective.

NORMAPME positions are the result of a wide consultation.

Consulted stakeholders are:

- all NORMAPME member associations;
- all UEAPME member associations;
- European industry associations which also include SMEs in their membership;
- any interested stakeholder representing SMEs can comment on draft NORMAPME positions.

Current drafts opened to consultation can be found HERE.

If your organisation represents Small and Medium Sized Enterprises and if you wish to be consulted in the future, please contact our Secretariat at info@normapme.com

We also participate in SME-representing expert working groups under UEAPME supervision, which have meetings every couple of months in Brussels. These forums allow us to have direct contact and feedback from experts representing SMEs in specific domains such as food, construction or environment.

Below you can find the most recent areas of our interest. Please feel free to contact us for more details or to share your comments.

You can address us by phone, fax or email in English, French, German, Italian, Polish and Spanish. For contact details to the relevant person in our office click here.

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-EC ONLINE CONSULTATION ON THE ALIGNEMENT OF TEN SECTORAL DIRECTIVES TO THE NEW LEGISLATIVE FRAMEWORK (CE MARKING)

New deadline for replies on the EC online consultation: September 15th 2010

In July 2008, the European Parliament and the Council adopted the New Legislative Framework (NLF), a set of measures enhancing the functioning of the internal market for goods and consisting, among others, of Decision 768/2008/EC establishing a common framework for the marketing of products.

Decision 768/2008 is designed to work as a guideline to regulators as it contains provisions that should be integrated into new and revised legislation.

Most of the comments we raised before the adoption of the New Legislative Framework were taken on board. Our main achievements in the package Decision (768/2008) have been the following ones:

1. Facilitated assessment procedures should be provided for small series production;
2. Notified bodies must carry out their assessment in a proportionate manner taking into accounts elements like size of the enterprise, serial characteristic of the production, complexity of the process, sector, etc.
3. Possibility for laboratories belonging to business associations to be accredited.

In this framework, the Commission has undertaken a process to align the first ten directives to the new provisions set by Decision 768/2008, launching an online public consultation that you can find using this link:
http://ec.europa.eu/enterprise/newsroom/cf/itemlongdetail.cfm?item_id=4289&lang=en

The consultation concerns the following directives:

1. Low Voltage Directive 2006/95/EEC;
2. Simple Pressure Vessels Directive 2009/105/EC;
3. Non-automatic Weighing Instruments Directive 90/384/EEC;
4. Civil Explosives Directive 93/15/EEC;
5. ATEX Directive 94/9/EC;
6. Lifts Directive 95/16/EC;
7. Pressure Equipment Directive 97/23/EC;
8. Measuring Instruments Directive 2004/22/EC;
9. Electromagnetic Compatibility Directive 2004/108/EC;
10. Pyrotechnic articles Directive 2007/23/EC.

Given the direct impact that the alignment of these Directives to Decision 768/2008 will have on European SMEs, we have prepared the enclosed draft position we would intend to submit to the European Commission as a further input to the questionnaire proposed in the EC online consultation.

Indeed, we believe that it is now of crucial importance that the SMEs friendly position we have achieved in the New Legislative Framework is implemented in each single directive.

On the other hand, we would be grateful if you could help us to formulate answers to the proposed questionnaire, as a very specific knowledge of each sector concerned is required.

Hence, we would like to encourage you:

1. to inform us as to which directives affected by the consultation you are more interested in
2. to send us your comments and inputs on the Commission's questionnaire as well as on our draft position paper;
3. to take part directly to the EC public consultation also using our proposed position by September 15th  2010.

For more information please contact:

Sara Gobbi
+32 2 282 05 45 s.gobbi@normapme.com

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- Calling all SMEs to participate in revision of standardisation package!

Standardisation and standards play an important role in SME daily activities as their products/services may need to comply with standards for legal and/or market reasons. The implementation of standards can be beneficial for SMEs if standards are:
-market driven; -fit for their business model;
-not used to make them go out of business by larger stakeholders;
-not developed by certifiers and/or consultants as business support means.

These provisions can principally be ensured by the participation of SMEs and their representatives in standardisation. Measures to improve the use of standards by SMEs, to facilitate the SME access to standardisation and the balanced representation in technical bodies need to be implemented.

Hence, we encourage you to contribute before May 21st 2010 to the public consultation on the revision of the standardisation package that the European Commission has just launched on this link!

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- Ecodesign Directive adopted by the EP: please prepare yourself to contribute to the Consultation Forum

Last 24th April MEPs adopted a legislative report on the Eco-design requirements for energy related products. The resolution was adopted with 394 votes in favour, 13 against and 3 abstentions.
The text is the result of a compromise achieved between Council and the EP referring to a Commission proposal to widen the scope of the 2005 Eco-design directive (which allows the Commission to set design requirements for energy-using products such as boilers, computers, televisions, etc), to include all energy-related products. Those are products that do not necessarily consume energy during use but have an indirect impact on energy consumption, such as construction materials and other devices used in houses (water taps for instance).
 
The Ecodesign Directive establishes requirements that energy-related products must meet if they are to benefit from free movement within the Community. It covers now energy-related products (excluding means of transport). For these, it will introduce mandatory minimum requirements that are set in "implementing measures" corresponding to the performance of the product. Those implementing measures are drafted with the cooperation of the Ecodesign Consultation Forum gathering industry, SMEs, consumers and national authorities. It is crucial that NORMAPME and UEAPME are present within this Forum for shaping the next implementing measures when it will come to construction materials and other devices! For this, we call for your help to suggest experts (issues discussed are very technical ones) to accompany NORMAPME and UEAPME staff in attending the meetings of this Forum. Please consider that the first measures will be probably drafted as of mid-2010. NORMAPME will keep you informed of the products following under implementing measures as soon as a working plan is issued by the EC.

From DG ENTERPRISE website please see below the procedure for adopting an implementing measure.
Any implementing measure has to be preceded by:

1.      A preparatory study
2.      A Consultation Forum (consultation of all stakeholders)
3.      An impact assessment
4.      A Regulatory Committee (vote by Member States)
5.      A scrutiny by the European Parliament

In principle, the Directive applies to all energy related products (except vehicles for transport) and covers all energy sources. Please consider also that not later than 2012 the Commission shall review the effectiveness of this Directive and of its implementing measures and possibly extend it to NON ENERGY RELATED PRODUCTS.

Please contact Ms Valentina Mauri v.mauri@normapme.com, +32 2 28 20 541, should you need any further details or should you want to suggest experts for your sector.

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EUROPEAN COMMISSION MANDATES ESOs TO DRAFT NEW STANDARDS

- M/432: Mandate to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directives 90/385/EEC and Directive 93/42/EEC relating to Medical Devices (issued on 24/11/08): this mandate aims at revising around 200 published harmonised standards as a result of the publication of Directive 2007/47/EC.

As mentioned in the mandate, Directive 90/385/EEC introduced "major changes to the essential health and safety requirements applicable to medical devices". The scope of "medical devices" includes softwares: "software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device." (Directive 2007/47/EC) Healthcare very often occurs in an SME environment  and even in a local environment, that it be in clinics, or laboratories, ambulance services, or in companies producing specific medical devices. Unfortunately, it is difficult to provide numbers: as stressed in the "Green paper on the EU Workforce for Health" published on the 10th of December 2008 by the European Commission, there is a lack of Europe-wide information on health workers and of "up-to-date, comparable data and information (...) on numbers of health workers" .

The standards that will be developed/revised accordingly to this mandate will be harmonised standards; they will be voluntary but will nonetheless be legal references, as they will reflect the essential health requirements of Directive 93/42/EEC; they will therefore have an impact on SMEs as manufacturers of medical devices (including softwares).

The full mandate can be found at the following e-address (in English): http://www.cenelec.eu/NR/rdonlyres/144B7979-77EA-4D7D-93C4-0D116C65E6D3/2387/m432en.pdf  

Please kindly note that another Mandate, M/433, also relates to Medical Devices, but with a tighter focus on graphical symbols for use in the labelling of medical devices containing phtalates. This mandate can be found at the following e-address: http://www.cenelec.eu/NR/rdonlyres/144B7979-77EA-4D7D-93C4-0D116C65E6D3/2386/m433en.pdf

Should you believe that the development of such standards at European level will have an impact on your business, NORMAPME invites you to express your interest and to suggest experts to be appointed to the future standardisation technical committees and working groups.

For more information or to express your interest: contact: Mr. Rémi Orth (direct tel: +32 2 282 0537)

-M/436: Mandate to the ESOs (CEN, CENELEC, ETSI) in the field of Information and Communication Technologies applied to Radio Frequency Identification (RFID) and systems (issued on 08/12/08): this mandate aims at preparing the development of a "complete framework for the development of future RFID standards"(phase 1) prior to the implementation of the standardisation work programme agreed in phase 1 (phase 2). 

All SMEs are concerned by standards on the technology that, as stressed in the mandate, "is of policy concern because of its potential to become a new motor of growth and jobs, and thus a powerful contributor to the Lisbon Strategy, if the barriers including a lack of interoperability to innovation can be overcome". RFID are seen as "the gateway to a new phase of development of the Information Society, often referred to as the "internet of things" in which the internet does not only link computers and communications terminals, but potentially any of our daily surrounding objects - be they food, clothes, consumer goods, etc."

The potential impact of the standards resulting from this mandate should be considered as very high for SMEs. RFID is seen as potentially redefining the market of goods and the way products, client relations, security... The scope is potentially extensively horizontal (virtually touching every business).

The full mandate can be found at the following e-address (in English):
http://www.cenelec.eu/NR/rdonlyres/144B7979-77EA-4D7D-93C4-0D116C65E6D3/2384/m436en.pdf

Should you believe that the development of such standards at European level will have an impact on your business, NORMAPME invites you to express your interest and to suggest experts to be appointed to the future standardisation technical committees and working groups.

For more information or to express your interest: contact: Mr. Rémi Orth (direct tel: +32 2 282 0537)

- M439: Mandate to CEN, CENELEC and ETSI for Standardisation in the field of standby and off modes power consumption measurement for energy using products (EuPs) (issued on 17/12/08): this mandate addresses ecodesign requirements for standby and off-mode electric power consumption of electrical and electronic household and office equipment.

Manufacturing of electrical and electronic household and office equipment is a horizontal field in which SMEs are involved. The mandate relates to Directive 2005/G19/EC and to Council Directive 92/75/EEC and states that a harmonised standard should be developed to cover the Directives' essential requirements.

Standards on energy measurement procedures should be "as uncomplicated and easily reproducible as possible", as stated in the mandate; the potential impact of verification procedures could be additional costs for SMEs.  

The full mandate can be found at the following e-address (in English): http://www.cenelec.eu/NR/rdonlyres/144B7979-77EA-4D7D-93C4-0D116C65E6D3/2382/m439en.pdf

Should you believe that the development of such standards at European level will have an impact on your business, NORMAPME invites you to express your interest and to suggest experts to be appointed to the future standardisation technical committees and working groups.

For more information or to express your interest: contact: Mr. Rémi Orth (direct tel: +32 2 282 0537)

- M/426: Microbiological Analysis of Cosmetics Products: new mandate accepted by CEN

Background
The European Commission has mandated CEN to draft standards on Microbiological Analysis of Cosmetics Products. The mandate has been accepted by CEN which decided to set up TC 399 that supersedes the former Task Force 181 as of last January 2009.

Justification for the mandate
The Scientific Committee on Consumer Product (SCCP) mentioned that it is necessary to carry out routine microbiological analysis of each batch of the finished product coming on the market. As no methods on identification of microbiological contamination are currently defined at Community level, the creation of a standard in this area would be the best approach.
The European standard will cover the following areas:

- General instructions from microbiological analysis;
- Detection of candida Albicans, of Escherichia Coli, of Pseudomonas aeruginosa, of Staphylococcus aereus and enumeration and detection of aerobic mesophylic bacteria.

CEN is taking into account the work undertaken by international standardisation organisations.

As a large number of SMEs and Craft companies are present in the market, NORMAPME appointed an expert (Ms Laurence Mulon) to be present for defending SMEs interests and representing SMEs and Craft companies of cosmetics sector during the whole standardisation process.

Should you have any interest in this issue please do not hesitate to contact Ms Mariette Wennmacher, m.wennmacher@ueapme.com, +32-2 282 05 33.

- Two New EC mandates on Bio Based products:

- M/429: CEN, CENELEC and ETSI mandate for the development of European standards on Bio-based Products.

- M/430: CEN mandate for the development of European Standards and CEN Workshop Agreements for Bio-Polymers and Bio-Lubricants in relation to Bio-Based products aspects.

Justification for the mandates
Following the EU's Innovation strategy, and following the Commission communication 'A Lead Market initiative for Europe, it has been underlined that one of the six lead markets is the bio-based products one.
The used definition of BIO-based products is: non food products derived from biomass (are excluded pulp, paper, wood and bio-mass as an energy source).
Bio: renewable biological resources.

NORMAPME aims to inform SMEs on this specific matter since we estimate that a large number of SMEs are present in the market.
Consequently, NORMAPME invites the interested SMEs to read the mandates you can find through the following link:
http://ec.europa.eu/enterprise/standards_policy/mandates/database/index.cfm?fuseaction=genSearch.main and to  express to CEN and to their respective NSOs their views or concerns on the opportunity of developing new standards (or series of standards) on the basis of the above mentioned mandates.
In addition, should you be convinced on the appropriateness and usefulness of developing such standards at European level for your business, NORMAPME invites you to propose experts to be appointed to the future CEN TC working groups. Please consider those TCs and-or working groups will be possibly set up only in case the CEN decides to accept the EC mandates.  

For more information please do not hesitate to contact NORMAPME Secretariat, info@normapme.com, +32-2 282 05 30.

An overview of the mandates published in the last 12 months and an assessment of their relevance to SMEs can be found HERE

An overview of draft mandates recently issued by the European Commission and an assessment of their relevance to SMEs can be found HERE

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