logo
European Weighing Industry
Newsletter Issue #5 - October 2015
Versión Española
Version Française
Versione Italiana
Wersja Polska

LMG lobbying: Outcome of the EC meeting

On 4th September the lobby team within the LMG met the European Commission (EC). From CECIP, Karlheinz Banholzer, Daniel Meier and Bárbara Morales attended the meeting, while from DG GROW, the Head of Unit B4, Mr. Maciej Gorka, and the Policy Officer Mr. Daniel Hanekuyk were present.

One of the main topics discussed was the WELMEC Guide 7.2 “Software for MI's”. CECIP deeply explained its reasons for rejecting that guide. The main reason is that the solution of Guide 7.2 is a valid one but it is not the only solution. Therefore, CECIP calls for the rejection of Guide 7.2 until there is an additional guidance reflecting alternatives in development. CECIP explained that software can be falsified. Therefore, CECIP will propose more technical solutions and will provide one valid alternative to avoid falsifications of software and one example showing that with Guide 7.2 falsifications can be done. Those proposals from CECIP will be discussed at the next WG7 (Software) and wgMI meetings.

CECIP also discussed about the new EN45501:2015. It seems that are some delays in the translation into the different language versions of the Member States. The EC informs that on 14th September 2015 the EN45501 was published as a harmonized standard and therefore is, from that moment, into force in all Member States. In any case, CECIP will raise in the next wgMI meeting a question about the status of the publication of the translation of the standard in the different Member States.

Last but not least, CECIP brought once more into the table the topic of the lack of transition period of the new NAWI and MID Directives and the problems that will cause to the weighing industry. However, the EC informed that there is no legal possibility of introducing a transition period in those Directives. Thus, CECIP proposed a solution concerning the labelling that could fulfil the requirements of the new and the old NAWID, i.e. Directives 2009/23/EC and 2014/31/EU. The EC proposed to have a creative solution, e.g. with a sticker which can be placed with a redesigned label accordingly to the new marking of the new directive which can be disposed exactly to the date of the new directive.

In addition, CECIP was informed that at the moment the Commission is conducting an evaluation on the Prepackages Directive. It should be finalized by October 2015. On the basis of the outcome of such evaluation the Commission will draft a report which will be submitted to the European Parliament by December 2015 or January 2016. CECIP participated in the public consultation on the Prepackages Directive launched by the EC.

The LMG lobbying team will meet the Commission in the first half of November to discuss some other topics which are of high interest for the weighing industry, such as the Prepackages Directive and the call for harmonization of the in-service instruments (legal for trade) within the internal market. We will keep you posted.

Karlheinz Banholzer
President of LMG

 

The in-service requirements relating to weighing instruments

by Ian Turner, Vice-President of LMG

The requirements that relate to the control of both automatic and non-automatic weighing instruments after they have been placed on the market are the remit of national authorities. This has led to a myriad of different requirements both in terms of the different economic actors that undertake various official procedures or the technical or legislative interpretations that have been made with regard to weighing instruments.

These inconsistencies create many problems for businesses as they have to be familiar with a wide range of often contrary requirements differing frameworks create a barrier to the free movement of goods and services with companies invariably having to design there internal procedures to meet the most onerous “local” requirements.

To illustrate this point; all Member States have requirements that instruments must undergo a re-qualification procedure after a repair or alteration. There is however a wide discrepancy between Member States as to what degree of change constitutes a new instrument. This is turn will dictate which economic actor can undertake the procedure of re-qualification; if it is a new instrument it can be the manufacturer, if it is repaired, in some Member States it can be the manufacturer in other it is only the authorities.

The problems created by this have been approached by a number of national associations. The German and British associations have spoken to national MEP’s and the Spanish association has managed to get a number of questions posed in the European Parliament. The questions focused on whether the European Commission had any intention of regulating the in-service requirements of weighing instruments. Unfortunately it became clear that this was not the intention of the Commission. This was not the response that we were hoping for but the Spanish MEP offered us some important advice on how to pursue this matter further. They suggested that we should:
  • Submitting more questions to the EC through MEPs from different nationalities in a joint manner;
  • To do an event at the European Parliament to present the topic;
  • To request a meeting with the Commission; and
  • To do a press conference on this matter.
We must see the helpful suggestions from the Spanish MEP as positive support in this area. The BTG are considering these suggestions and it is planned that we will continue with this matter as it is having a significant detrimental effect on the European weighing industry.

 

Responsibilities of importers, distributors, manufacturers and authorised representatives under the new Directives 2014/31/EU and 2014/32/EU

by Ian Turner, Vice-President of LMG

The new Directives contain requirements for all economic operators in the supply chain. There are four categories created by the Directives and each type of operator will have new and clearer obligations depending upon their position in the supply chain.

Manufacturer - Importer

A manufacturer is any legal or natural person who manufactures an instrument or has an instrument designed or manufactured, and markets that instrument under his name or trademark.
Importers are those businesses that are first making an instrument available on the market or putting it into service within the EU.
There are a number of new obligations that both the manufacturer must have positive process in place to ensure compliance with the requirements.

Markings –name and address for manufacturers and importers

The instrument must now be marked with the name, registered trade name or registered trademark and the postal address of the manufacturer and importer. The requirement for the postal address is new. This must be single point at which the manufacturer or importer can be contacted, so the name and address of national agents in other member states is unlikely to be acceptable.
These markings must be in a language easily understood by the end user, so it is very likely that different languages will be required for this information.
The obligation for importers is slightly different in that the information can be given on packaging and accompanying documents if the only reason that the importer has to open the packaging will be to apply the information.

Markings- CE Mark and supplementary metrology marks

For the purposes of the NAWI Directive the green M will go and it will become a letter M and the last two digits of the year in which it was affixed, surrounded by a rectangle at least 5 mm high. This means it will be the same as the MI Directive.
The CE and the other supplementary metrology marks must be placed on the instrument before it is placed on the market, the supplementary marks must immediately follow the CE mark and identification number (the notified body number) must follow these marks.

The Declaration of Conformity

The format for the Declaration of Conformity can be found in Annexes of the Directives and these should be followed. There should only be one Declaration of Conformity for all relevant directives.

Instructions, information and technical files

The manufacturer or importer must ensure that the instrument is accompanied by instructions and information in a language which can be easily understood by end users in the member state in which it is made available or placed on the market.

Other requirements-Manufacturers

Manufacturers must have procedures to ensure that production remains in conformity with the requirements of the Directive.
When deemed appropriate with regard to the risks presented by the instrument they shall carry out sample testing of the instrument and if necessary keep a register of complaints, of non-conforming instruments and keep distributors informed of any such monitoring. It is assumed that the majority of manufacturers will be carrying out appropriate testing but the obligation to keep distributors informed is a new one.
If the instrument has already been placed on the market and the manufacturer believes that it may not be in conformity with the Directive they shall immediately take corrective measures to bring the instrument back into conformity. This could have far reaching implications for the control of software. If, for example, a manufacturer believes that security patches are necessary it appears they should supply these immediately.

Other requirements –Importers

An importer must ensure that the correct conformity procedures have been followed and that the manufacturer has drawn up the appropriate technical files and applied the correct markings.
If the importer considers or has reason to believe that an instrument may not comply with essential requirements they shall not place the instrument on the market until it has been bought back into compliance and shall inform the manufacturer and the market surveillance authorities.

Obligations of distributors

A distributor is any person who is not the importer or manufacturer who makes an instrument available on the market. This will create specific obligations for many businesses that were not included previously.
The distributor must undertake the following actions and have procedures and evidence to support that they have completed them.

  • They must take due care in relation to the requirements of the Directive.
  • Before making an instrument available on the market they must verify that all of the markings and all the required documentation is with the instrument.
  • They must confirm that the manufacturer or importer have met their obligations.
  • If distributor has reason to believe that an instrument that they intend to supply is not in conformity with the Directive they shall not make it available on the market until it has been bought back into conformity.
  • If the instrument presents a risk they shall inform the manufacturer, importer and the market surveillance authorities. This is a new and potentially onerous obligation.
  • If the distributor believes it is not in conformity and it has already been supplied, they shall take corrective measures to bring it into conformity. If it presents as risk they shall inform the competent national authority.

LMG meeting in London

By Karlheinz Banholzer, President of LMG

The last LMG meeting was held in the offices of the UK Weighing Federation. CECIP, and especially the LMG, would like to thank them for offering such a possibility. Their hospitality and location was unforgettable.

In that meeting, the follower of the General Secretary Bárbara Morales, Friedrich Trosse was introduced.

With 12 participants, including the General Secretary, one of the main topics discussed was the identification of the mid and long term legal metrology topics.

In addition, a new approach on how to work together was defined. In this regard, the responsible Rapporteurs will draft a short sum up after a meeting to inform all the LMG members about the present situation and discussions of each working group.

The short term topics were well prepared, discussed and released for the next step. The main topics discussed in that meeting were the following: EN45501, POS Guide, Risk Assessment, EC Meeting, Database for national regulations, international co-operations, topics for the next newsletter, eCompliance and the Seminar to be held at the GA 2016 in Vienna.

There was a very fruitful discussion during the meeting surrounded by a very enthusiastic working environment.

The next LMG meeting will be held at the Dutch Weighing Association offices (FHI offices) in Leusden, the Netherlands. I hope to see all the LMG members there for a motivating and fruitful meeting!

 

Software

by Ian Turner, Vice-President of LMG

Software has become perhaps the most significant part of the design, operation and manufacture of weighing instruments. This trend is likely to increase as instruments become increasingly networked and the use of cloud technologies becomes commonplace.

The present regulatory structure is based around the essential requirements of both the NAWI and the MI Directive and further developed in the WELMEC Guides 2.3 for NAWI's and 7.2 for Measuring Instruments. There are very important new software requirements in the new EN45501, which we must look at to ensure the implications are fully understood.

All of the existing frameworks are based around the notion of technical solutions to software control, outlining the risk classes for different architectures and corresponding technical solutions to ensure compliance with the directives. These frameworks do not consider procedural based solutions based on recognized standards of quality control and risk assessment to the control of software. Solutions such as this would introduce greater flexibility to allow the development of new software solutions and are supported by CECIP and all of the European manufacturers.

CECIP has made some success with WELMEC in opening up the debate on how procedure based solutions could operate in getting products to the market. Such a notion would be based on the use of recognized international quality standards that control the design and production of software in other sectors such as pharmaceuticals.

We have had some meetings on the procedural based systems and the ideas have been well received by WELMEC. It is planned the outline for procedure based software control will be considered at the next WELMEC meeting in November and we will keep you up to date with the developments. More information on this idea can be found on the CECIP website.

 

OIML MAA-Basic System

By Karlheinz Banholzer, President of LMG

The OIML, the International Organization of Legal Metrology has the aim to harmonize legal metrology requirements in the world. They develop model regulations, standards and related documents (e.g. OIML R76 for non-automatic weighing instruments) to be the basic for national legislation.

In 1991 the OIML Certificate system was introduced. This Basic Certificate System is designed to avoid repeating the test of the same instrument in different countries, to facilitate administrative procedures and reduce costs. The OIML Certificates may be accepted and utilized by any national metrology service or national responsible body in any country to generate Type Approval Certificates for the own country or region.

The MAA System was implemented in 2005. The intention is to replace the Basic System with more confidence between the Issuing Participants. This should be reached by accredited or peer assessed quality management systems between the Issuing Participant combined with supervision by OIML.

This transfer from the Basic to the MAA system is not possible for all the recommendations in a short time period. Therefore the Basic System should continue to be available whilst improving its quality to achieve a comparable level as the MAA system. This will be done by ensuring that participating laboratories have a quality management system in which executes measurements for issuing Basic Certificates.

The MAA system compared to the Basic System operates only peer assessed or accredited laboratories. The quality level of such laboratories would be on a comparable level and therefore it’s estimated to get a higher acceptance by the different countries.

If the OIML Conference decides to move a Measuring Instrument from the Basic System to the MAA System there is a two years transition period before the withdrawal of a basic certificate becomes effective. Revisions are still possible.

For more information please take a look to the OIML website:
http://www.oiml.org/en/certificates/maa/maa

 

EN45501- Where are we now?

by Ian Turner, Vice-President of LMG

The existing 1992 standard will expire on the 20th April 2016 and no new type approvals can be issued after that date. Existing type approvals can continue to be used until they expire. This is because of the excellent work done by the CECIP LMG in lobbying the Commission on this matter.

You must remember that on the same date you will need to ensure that your instruments meet the new marking requirements and that the Declaration of Conformity is in compliance with the aspects of the new Directive. There is no transition date for these requirements, so to be fully complaint you must meet the existing obligations on April 19th and the new ones the following day on April 20th 2016.

The CECIP LMG has lobbied the Commission on the problems that the lack of transition will create for both big and small businesses. As the implementation is a matter of national enforcement they were unable to offer a formal solution but have stressed to all Member States the importance of a pragmatic approach.

One of the results of the lobbying action done by CECIP is the letter issued by the Commission providing an official position regarding the validity of the TACs even once the new standard has come into force (LM13 021). According to that official letter, TACs will be valid till the end of their date of validity, i.e. 10 years. In such cases the market surveillance authorities can start a safeguard procedure.

 

CONTAINER WEIGHING AND IMO REGULATIONS
Weighing equipment necessary to meet new IMO regulations

by Vincent M. van der Wel, Vice-President CECIP and Friedrich Trosse, Secretary General

The International Maritime Organization (IMO) has decided to rely on the weighing industry to prevent future shipwrecks.

In 2014, the 169 member countries of the London-based IMO amended its SOLAS Convention, more precise the MSC circular 1475, to strengthen the protection against shipwrecks caused by wrong weight information. The new law requires all shipping containers to be accurately weighed, with the weight verifiable before they are allowed to be loaded onto vessels. This will enter into force by 1st of July 2016.

There are two methods of weighing the freight before transport. One will be to weigh the entire packed container when loading, the other is to weigh all of the content of the container, including packaging material. In both cases, national law shall determine what equipment and degree of accuracy is deemed fit for this purpose. There was a proposal that the shipper should also be allowed to calculate the weight by adding the weight of everything after an estimate, but this was deemed too inaccurate for its purpose.

In other words, every single item shipped from a port within the 169 member states of the IMO will in future pass a scale at one point before shipment.

The new requirements help guarantee the safety of ship and harbour crews. It is also intended to prevent accidents that can occur when ship contents fall overboard because a stack of containers’ centre of gravity is positioned too high or when a ship rocks, causing LASH (lighter aboard ship) vessels to be overloaded and break. Container stacks sometimes collapse because goods are incorrectly piled, and when a boat is not evenly balanced, it can affect a ship’s trajectory. Proper weighing and declaration is a requirement to avoid these situations. Weighing equipment has to take the guesswork out of weighing shipping loads, making the process of getting accurate results certain. Doing so ensures that loads will be rejected by the ship owner for not being properly weighed and verified.

At a recent seminar of the International Cargo Handling Coordination Association (ICHCA), several concerns were discussed, such as the discrepancy between country requirements around the world, as well as the short implementation period. It has further been mentioned that this new requirement has yet to appear on the agendas of many legal metrology authorities. It may therefore be wise for companies that see potential in that market to ask their national authority what their implementation plan will be, in order to be prepared to meet the upcoming demand.

 

Who is who: Notified Bodies- What are they?

by Ian Turner, Vice-President of LMG

In the European Union a notified body is an organisation that has been accredited by a Member State to assess whether a product meets certain approved standards. The assessment can include both the inspection and examination of a product or its design and manufacture.

The approvals that notified bodies can give is not limited to the legal metrology directives but will relate to all of those items in the single market that bear a CE mark such as electrical items, toys and medical devices.

For the metrology directives notified bodies undertake the design approval of new weighing instruments. This is the procedure that results in manufacturers obtaining a type approval for their instruments (Module B). Invariably this must be followed by the approval of those businesses to undertake the initial verification of their own instruments. This is known as module D.

Notified bodies also undertake the third party verification of weighing instruments. These are known as module F bodies and are quite common in some member states but less popular in others.

There are wide range of notified bodies across the EU that undertake all of these procedures and what is important to remember is that they are all private organisations that are in commercial completion with each other. All of the EU notified bodies are listed on a website known as NANDO:

http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.main

This website is useful as it allows users to find out which notified body has approved a weighing instrument from their identification number on the instrument.

CECIP members use a wide range of different notified bodies, the ones that you may regularly come across are:

The PTB: The German National Metrology Institute that is based in Braunschweig and Berlin. It is the national institute for natural and engineering sciences and the highest technical authority for metrology and physical safety engineering in Germany. It is a notified body for EC Type approvals and the notified body number is 0102.

The NMI: This is the Dutch notified body based in Delft and Dordrecht. It is notified for both EC Type approvals and EC Declaration of Type Conformity. The notified body number is 0122.

The LNE: This is the French notified body, based in Paris. It is notified in both EC Type approvals and EC Declaration of Type Conformity. The notified body number is 0071.

The NMRO: This is the British notified body based in London. It is notified in both EC Type approvals and EC Declarations of Type Conformity. The notified body number is 0126.

DELTA: This is the Danish notified body. It only undertakes EC Type Approvals and does not undertake EC Declaration of Type Conformity. The notified body number is 0199.

This list is not exhaustive and our members use all of the EU notified bodies, this includes SP from Sweden (NB 0402) and CMI from the Czech Republic (NB 1383).

There is a wide range of bodies undertaking third party verifications and these can also be found on the NANDO website.

Choosing the correct notified body is critical for your business and all of them have good and bad attributes. When choosing a notified body you should look at all aspects of the service that they provide to ensure that they can work with you in a busy and competitive market place.

 

Agenda

  • 4/09/2015 CECIP LMG – EC, DG GROW meeting, Brussels (BE)
  • 24/09/2015 CECIP LMG meeting, London (UK)
  • 29/09/2015 CECIP-CWIA (Chinese Weighing Instruments Association) meeting, Frankfurt (DE)
  • 08/10/2015 CECIP Board meeting, Teleconference
  • 7-9/10/2015 WELMEC WG2, Bratislava (SK)
  • 13-14/10/2015 WELMEC WG8, Berlin (DE)
  • 19/10/2015 CIML Seminar, Arcachon (FR)
  • 20-22/10/2015 CIML meeting, Arcachon (FR)
  • 28/10/2015 Blue Guide meeting
  • 28-29/10/2015 WELMEC WG7, Vienna (AT)
  • 11-12/11/2015 WELMEC WG5, Prague (CZ)
  • 20/01/2016 wgMI meeting, Brussels (BE)

 

© 2009 - CECIP