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European Weighing Industry
Newsletter Issue #7 - March 2016
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The New Legislative Framework: The New Directives

Don’t forget that the new non-automatic weighing instruments (NAWI) and the new measuring instruments (MI) Directive come into effect on the 20th April 2016, just a few weeks away

These directives will implement some major changes to the way in which we work, the documents we supply and the markings that must go on the instruments.

There are now four categories of economic operator outlined and each type will have new and clearer obligations depending upon their position in the supply chain. The four categories are manufacturer, importer, authorised representative and distributor

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.

The status of the authorised representative is the same as the previous directives

Markings –name and address

The instrument must now be marked with the name, registered trade name or registered trademark and the postal address. The requirement for the postal address is new. The address must be single point at which the manufacturer or importer can be contacted, so the name and address of national agents is unlikely to be acceptable

The other extra burden with these requirements is that end users must in a language easily understand it, 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

The requirements for the CE mark are not changed.

For the NAWI Directive the M mark is no longer the same as the existing 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.

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 this:

These markings are unchanged for the purposes of the Measuring Instrument Directive

The Declaration of Conformity

There is a new format for the Declaration of Conformity and there should only be one Declaration for all relevant directives. The format can be found in the annexes of the Directives

As with all of the other document requirements, the declaration of conformity must be in a language of the member state where the instrument is made available or placed on the market. This will probably mean that you will need to have these declarations translated into the language where your instruments are made available or placed on the market

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.

If a manufacturer or importer receives a reasoned request from an enforcement authority, they must provide all of the information necessary to demonstrate conformity with the instrument in a language, which can be easily understood by that authority

This requirement may turn out to be very onerous, as the entire technical file may need to be provided in the language of the member state making the request

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.

Depending upon how this obligation is interpreted this could be an onerous obligation and manufacturers should be putting procedures in place to ensure that distributors can be informed of any such monitoring.

Other requirements –Importers

The other requirements for importers are slightly different from those of manufacturers.

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. This will involve a process or procedure to demonstrate that these checks have been made.

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 specifically 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 obligations
  • 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


It is most important to remember that if an importer or distributor places the instrument on the market under his own name or modifies an instrument already placed on the market they will be considered to be the manufacturer.

by Ian Turner

 

CECIP General Assembly 2016

Dear CECIP Members,

I am glad to announce that the planning stage has come to a successful end and we can finally officially invite you to our 66th General Assembly. This year our Austrian member association, Bundesinnung der Mechatroniker, was so generous to host us in their capital Vienna.

The date is a little later than usual, as the General Assembly will be held at the Austria Trend Hotel Savoyen on the 3rd of June, and will be surrounded by a program starting on the 1st on June with an open LMG meeting. The conclusion will be an excursion in Vienna, including a city tour and Lunch at a traditional Austrian wine tavern. On Friday we will also have a Gala Dinner at a castle outside of Vienna.

There will be 3 guest speakers. The first is Mr. Schwartz, vice president of the German metrology institute PTB. and in furthermore we will hear from Mr. van Schagen, Chairman of the Board of the Branche Industriële Elektronica (FHI) from the Netherlands. The speaker of the Austrian association will still be determined.

A novelty this year is a stronger participation by our international partners from Japan, China and the USA. Even though some have not yet officially confirmed to attend, they have shown great interest and are happy to attend and introduce themselves to the CECIP members.

Of course there will also be a partner program. On Friday the 3rd there will be a tour through the alleys of the first district of Vienna, the historic center, concluded by a lunch in a typical Viennese restaurant.

We hope to hear from you soon, and to welcome you all in Vienna.

Kind regards,

Friedrich Trosse,
CECIP General Secretary

 

How to prevent Cybercrime

by Friedrich Trosse, CECIP General Secretary

During the yearly AWA-PTB talks in Braunschweig, the German Federal Police Unit in charge of combating Cyber Crime gave a presentation explaining what Cyber Crime is, who possible Cyber Criminals are, and how companies can protect themselves against possible attacks.

Generally Cyber Crime can take many forms. Of course most of us think of hackers, but the field of hackers has drastically changed over the years. While some years ago hackers were still highly educated computer experts, it is now possible to hack even with basically any knowledge so-called hacker tools, which are available for free on the internet.

This has changed the motives from the criminal or even government agent to bored teenagers who may abuse the easily accessible technology just for fun.

However of course there is also planned industrial espionage. These can also come from several sources, be a disgruntled former employee to competitors to even state actors.

Mr. Pursche mentioned one way to combat industrial espionage which may seem obvious, but is still often overlooked: The physical control of the factory site. While everybody surely thinks of strangers walking onto the site, there have been cases where people simply planted several USB Flash Drives containing spyware on the parking lot, and indeed someone finally put it in their work computer.

Of course it is difficult to watch such a parking lot or other entrances all day and night. Therefore it is just as important to raise awareness among the employees about such issues. The best way to prevent attacks is to sit down employees and make them aware of the dangers of a USB flash drives, suspicious cables or other electronic devices that seem to appear out of know where.

Additionally, it is important to also plan for the case when an attack cannot be prevented. The best way to prevent data loss is to have all data and communication professionally encrypted. This way stolen data will not be useless, or will at least require great effort to read, which works as a strong deterrent. Additionally every company should assess what data must be made available to whom. In many cases the sales department will never access blueprints that are used by an engineering team, so why not deny access for the case of an attack?

Finally, a company should also have a plan on how to react to such an attack. In case a staff member notices suspicious behavior, this can be treated like a fire drill. Every team member should know who to talk to, what to report, and how to secure data and traces to the perpetrators.

In the end, awareness of the danger is the most important step towards security. For further information please contact the CECIP Secretariat.

New EU law on food information to consumers - Nutrition labelling becomes mandatory in Europe

By Javier Deniz

While food information on labels in the US has been rigidly regulated since the early 1990s, a similar level of uniformity was only recently introduced in Europe. After 8 years of negotiations, on 25 October 2011, the European Parliament and the Council adopted Regulation (EU) No 1169/2011 on the provision of food information to consumers .

The new Regulation modifies existing food labeling provisions in the Union to allow consumers to make informed choices and to make safe use of food, while at the same time ensure the free movement of legally produced and marketed food. It is applicable to all member states of the European Union (EU).

It entered into force on 12 December 2011 and applies since13 December 2014, with the exception of the provisions concerning the nutrition declaration which shall apply from 13 December 2016.

The new regulation makes nutrition labelling mandatory for pre-packed food and instructs food manufacturers to provide information on the energy value and 6 nutrients: fat, saturates, carbohydrate, sugars, protein and salt – in this order, and expressed per 100 g or per 100 ml of product.

This information should be presented in a nutrition table in the same field of vision and may, in addition, be expressed on a per portion basis.

Further nutrients (i.e. monounsaturates, polyunsaturates, polyols, starch, fibre, vitamins and minerals) can be included voluntarily.

As stated in Regulation 1169/2011, for the majority of food packaging labels a minimum font size of 1.2 mm is required for all mandatory food information. Additionally, voluntary information (e.g. slogans or claims) must not be presented in a manner that impinges on the presentation of mandatory information.

Most producers of CECIP involved in the manufacturing of labelling equipment for the food retail and industry had already adapted their products to comply with the requirements of the Regulation applied since 13 December 2014. From CECIP we encourage all of them to incorporate the nutritional information, helping their customers to comply with it from 13 December 2016.

Finally, we shouldn’t forget what the Health and Consumers Directorate-General of the European Commission, in its guidance document for competent authorities for the control of compliance with EU Regulation 1169/2011, says: “Official controls shall be applied, with the same care, to exports outside the Union, to the placing on the market within the Union and to introduction from third countries. Member States shall also take the necessary measures to ensure that products intended for dispatch to another Member State are controlled with the same care as those intended to be placed on the market in their own territory”.

 

CECIP communications update

by Friedrich Trosse, CECIP General Secretary

For the last years, the media presence and communication of CECIP has mostly relied on our website, as well as on this Newsletter. During the last Board meeting it was decided to update and expand this presence.

As a first step, CECIP is currently testing a new forum, which in future can be used to exchange information and to discuss matters regarding the weighing industry. As soon as the new Forum is perfected we will supply you with instructions on how to register and use it.

Additionally, we have added an updated version of our presentation to our website, where it can be viewed and downloaded for you to use. Also, we have added shortpolicy statements about current projects taken on by CECIP in order to keep you posted on our activities.

And last but not least, CECIP has created its own Twitter account: https://twitter.com/CecipWeighing

We will use this channel to inform regularly about matters concerning the Weighing Industry, so please follow us under @CecipWeighing.

 

The Convention on the Safety of Life at Sea (SOLAS)

By Ian Turner

The International Maritime Organization (IMO) is part of the United Nations, and is based in London. It has existed since 1948 and with 169 member states.

One of the functions of the IMO is the creation and administration of The International Convention for the safety of human life at sea (SOLAS) The SOLAS Convention was first drafted in 1914 after the sinking of the Titanic

(IMO) has amended Chapter VI (Regulation 2) of the SOLAS Convention to require, as a condition for loading a packed container onto a ship for export, that the container has a verified gross mass. The shipper is responsible for obtaining the verified gross mass of a packed container and communicating it to the ocean carrier.

This requirement will become mandatory on 1 July 2016 and will apply globally.

After that date, it would be a violation of the SOLAS Convention to load a packed container onto a ship if the ship operator and marine terminal operator do not have a verified container gross mass.

The important points for CECIP members to note are that the new requirements create two methods for obtaining the gross mass of a packed container. These are known as method 1 and method 2

Method 1 - Weighing the packed container using calibrated and certified equipment; or

Method 2 - Weighing all packages and cargo items, including the mass of pallets, dunnage and other securing material to be packed in the container and adding the tare mass of the container to the sum of the single masses, using a certified method approved by the competent authority of the State in which packing of the container was completed.

The requirements further clarify that calibrated and certified equipment means a scale, weighbridge, lifting equipment or any other device, capable of determining the actual gross mass of a packed container or of packages and cargo items, pallets, dunnage and other packing material, that meets the accuracy standards and requirements of the state in which the equipment is being used.

To date there has been no clear statement form the majority of member states or the EU Commission as to what the appropriate accuracy standards and requirements are. CECIP are lobbying for those standards and requirements to be compliance with the present Directives 2014/31 and 2014/32. This would mean that any instruments used for the purposes of the SOLAS Convention would need to be type approved and verified if they were to ensure that full compliance would be met. In practice this would mean that non-automatic weighing instruments would need to meet the requirements of EN45501, have a type approval document and be verified. Automatic Weighing Instruments would need to meet the requirements of annex MI-006, have a type approval and be verified

 

Overview over WELMEC Reports

by Friedrich Trosse

Report WG 8:

On the EU level there was a new Blue Guide published. The commenting period ended on October 28th.

The new WELMEC guide 8 is finished and ready for release.

WG 7 and 8 will be focusing on risk assessment; WG 8 will mostly focus on the metrological aspects.

Furthermore, CECIP participated in the revision of WG 8.3 regarding MID application Module B.

Regarding the modification of an instrument there has been no final resolution. Our cooperation partner CECOD pointed of the impossibly high costs regarding the problem of conformity assessments. There will be a questionnaire answered by Ms. Fuchs of the Austrian metrological authority regarding this problem by the end of December 2015.

Furthermore WELMEC raised the issue of using the proper labelling on the measuring instrument.

Report WG 2

No work has been done regarding 8.16-5 on Automatic Rail Weighbridges

Also Guide 2.3 will not be transferred into guide 7.2

WG2 sub-group Guide 2.6/1 (Catch-weighers) and 2.6/2 (Gravimetric filling instruments) will be reviewed as part of the WG2 review of the structure of all of the Guides. There are however no documents regarding this issue.

What is relevant for CECIP is that we must continue to raise with both WG5 and our regular meetings with the Commission the fundamental importance of market surveillance to the industry. This must be done by collecting an evidence base of the types of instruments where we believe there may be a high risk of contravention.

This could be achieved by:

1) Completing our own research amongst member countries as to where the highest level of contraventions are occurring

2) To review individual member states market surveillance reports

Report WG 5

The last meeting was attended by Karlheinz Bahnholzer for which a report has been issued and is attached. Karlheinz has agreed to take on the responsibility as the co-rapporteur.

There will be another WG5 meeting in April or May 2016. It is the intention of CECIP to make a presentation outlining the areas that we believe that combined market surveillance projects should consider

It is proposed that we suggest that EU market surveillance projects should consider the internet supply of price computing non-automatic weighing instruments. This must be evidence based from the market place

We would like to consider other possibilities such as

1) The use of non-approved scales for medical purposes

2) The use of non-approved scales for the supply of precious metals and stones

We at CECIP must continue to raise with both WG5 and our regular meetings with the Commission the fundamental importance of market surveillance to the industry. This must be done by collecting an evidence base of the types of instruments where we believe there may be a high risk of contravention.

This could be achieved by.

1) Completing our own research amongst member countries as to where the highest level of contraventions are occurring

2) To review individual member states market surveillance reports

Report WG 7

  • The amalgamation of the Guide 2.3 and the 7. This will now not go ahead
  • It was agreed that the CECIP idea could bring benefit to the development and control of the market place. One of the main elements that would need to be explored further is the development of a clear and transparent risk assessment process. It was decided to return to the development of the CECIP procedural based notion once WG7 had explored in more detail the development of risk process.
  • The proposed WG7 risk assessment procedure is based on the concepts of ISO 27005 and ISO 15408. The broad notions proposed so far are generally supported by CECIP. It is CECIPs view that the major weakness of the proposal is a measurement of likelihood or motivation without which we believe it is unlikely the project could reach fruition. CECIP is involved in the working group on this project and contributing to its development
  • The Guide 7.2 (V6) Has been agreed by the WELMEC committee and has been discussed by the Commission: There are two matters that we continue to object to: a) The assumed risk of class C for automatic weighing instrument b) The continued failure to recognise a risk based process for the development and control of software. It is felt that if the risk assessment project in 3 above can be developed both of these objections could be resolved

 

CoMeLab – Committee of Italian metrological manufacturers and laboratories

by Massimo Mai

CoMeLab is a committee within the National Association COMUFFICIO and represents all companies involved in manufacturing, selling or service of weighing equipment. Within Italy, CoMeLab represents circa 30 companies, 271 laboratories qualified to perform periodic verification and 11 MID laboratories. In total it represents about 1800 employees.

It is necessary to mention that COMUFFICIO was founded in 1945, and represents 1300 companies providing digital and computing services in the the retail and office automation sector.

The CoMeLab Committee was founded on the 3rd of December 2014 and became a member of CECIP at the 65th General Assembly in Barcelona.

The aim of the Committee is to represent the sector at institutional level, but also to provide information and services to its members regarding legal metrology, normative issues as well as business and trade advice.

The president pro tempore of CoMeLab is elected is member of the Consiglio Direttivo, the directive council, which also includes 18 Council members which are elected by the general assembly in a plenary session.

Since its inception, CoMeLab has searched and consolidated a collaboration with the Italian Ministry of Economic Development, with Unioncamere, the Union of Italian commercial, industrial, artisanal and agricultural chambers. Unioncamere is the main market surveillance body in Italy. CoMeLab also collaborates with the Italian accreditation body ACCREDIA.

Among the first issues brought forward by CoMeLab at the Italian institutions was the request to establish uniform normative processes with strict and simplified administrative procedures. Another was the monitoring of the transposition of Directive 2014/31/EU and 2014/32/EU.

Another area of CoMeLab activity is professional formation of practitioners in the weighing sector. At the moment there are systematic courses for operators of metrological laboratories as well as for administrative staff. There will also be seminars intended to keep representatives of the member companies up to date with recent normative changes and requirements. Of course there are also courses on other areas needed for a successful enterprise, such as commercial, administrative and informatics seminars.

In accordance with the main Italian certifying bodies, CoMeLab has started proceedings to facilitate transition from ISO 9001:2008 to ISO 9001:2015; and important process which has been initiated at the National Convention which took place on 29th of October 2015.

On an international level, CoMeLab is an active member of CECIP, and our representatives take part in CECIP activities.

To contact CoMeLab, you can reach us under comelab@comufficio.it.

 

Agenda

  • 06-07/04/2016WG 5 Meeting, Stockholm (Sweden)
  • 20/04/2016NoBoMet Meeting, Berlin (Germany)
  • 01-04/06/2016 CECIP General Assembly Vienna (Austria)

 

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