Non-automatic weighing instruments
Royal Mail Easiweigh products: Are these devices "non-automatic weighing instruments" for the purposes of directive 90/384/EEC and the corresponding UK regulations?
It is NMO's opinion that these devices are not non-automatic weighing instruments and therefore do not need to comply with the requirements of the directive/regulations.
How do the OIML R76 (1992) requirements for non-sutomatic weighing machines compare with the requirements in the USA?
NMO has carried out an intercomparison between the USA's requirements of Handbook 44 with the OIML recommendation R76 (1992).
I understand that a number of other countries will be joining the EU and that directives, like directive 90/384/EEC on non-automatic weighing instruments, will apply to those new members. Where can I find the official papers on this? Which countries will be joining and when?
The conclusions of the Ministerial meeting in October 2002 can be found at:
http://www.eu2002.dk/
This lists the countries concerned.
Can NWML grant a European type approval for a non-automatic weighing instruments (NAWI)?
Yes. New instruments intended for the EEA market place (EU plus EFTA except Switzerland) which are in use for trade, used for medical purposes (weighing patients and medicines) and in the applications of laws (subject to existing transitional arrangements up to the year 2002), may be granted EC Type Approval. These instruments are subject to the provisions of the Council Directive 90/384/EEC, as amended, which is implemented into UK law under "The Non-automatic Weighing Instruments Regulations 2000 (SI 2000 No 3236, as amended).
All electronic and most mechanical non-automatic weighing instruments (NAWI's) used for the above purposes have to be type approved. For type examination, instruments need to meet the essential requirements of the Directive 90/384/EEC. The metrological aspects of the instrument can be assessed against the requirements of the European Standard EN45501. Meeting the requirements of EN45501 provided presumption of conformity with the corresponding essential requirements of 90/384/EEC.
Must a non-automatic weighing instrument (NAWI's) meet the requirements of EN45501 to get approval?
Not necessarily. As previously stated, the instruments must meet the Essential Requirements of the Directive 90/384/EEC. Meeting the requirements of EN45501 is merely one way of demonstrating conformity with the Essential Requirements. Other equivalent standards may be used. However, designing the instrument to meet EN45501 is usually the easiest route for the manufacturer to take.
How do I find out if my customers weighing instrument can be converted to weigh in metric units?
Most weighing instruments which weigh pre-packed goods where required to be converted to weigh in metric units (kg or g) in 1995. To complete the metrication process, from 1 January 2000 all sales of loose goods by weight, at retail or wholesale level, are required to be in metric units.
To find out if it is possible for your weighing instrument to be converted to weigh in metric units you will need to contact NWML. Before contacting NMO you will need to obtain the following information:- manufactures name, model number and type approval certificate number. This information can usually be found on the rating plate attached to the side or rear of the instrument.
If the type approval has been granted by NMO then we will probably be able to give you an immediate answer. If the approval had been granted by another Notified Body within the EU then we will probably advise you to either contact the Notified Body direct or to contact the UK Weighing Federation on 01604 622023 for further advice.
Records of public weighings - Is it lawful for the records of public weighings required to be retained under section 20 (offences in connection with public equipment) of the Weights and measures act 1985 to be kept in electronic form?
Section 20 of the act mentions a number of classes of "persons". For the purposes of this reply only two of those classes are relevant. In the first place the "person appointed to attend" is required by section 20(2)(c) to deliver a statement in writing. This is of the weight or other measurement found. Until such time as any changes in connection with electronic commerce may be introduced, this statement must continue to be a written statement.
In the second place the "responsible person" under section 20(5) is required to retain records for a period of not less that two years. These are the composite records of all the weighings or other measurements found. They must be capable of being produced, when requested by an inspector in accordance with section 20(6). It is not, however, a requirement that they must be written or printed paper records. The use of electronically stored "tally roll" records or Data Storage Devices (DSD), such as silicon flash EPROMS and Hard Disc storage has been allowed for many years, as long as there is adequate security, both software and hardware, built into the system. WELMEC Guideline 2.5 sets out, in section 6, requirements relating to DSDs, which should be met. (For previous related guidance see WM 393)
(WELMEC publications are available on the WELMEC website, www.welmec.org )
How are the hardware and software of POS devices connected to non-automatic weighing instruments (NAWI's) approved?
The POS device connected to a particular non-automatic weighing instrument (NAWI) could be approved as a complete weighing system and an EC type approval certificate issued. Alternatively, the hardware and software of the POS device could be examined and tested separately and a Test Certificate issued.
The advantage of having Test Certificate issued is that the connection of the POS is not limited to a particular NAWI as the Test Certificate state that it may be connected to any compatible NAWI which is allowed in its Type Approval Certificate to be connected to a POS.
There are requirements for the software security for POS devices. NMO should be contacted at an early stage in the design and development process so that these requirements can be met.
Modules, peripherals, or major parts of weighing instruments can be tested as separate parts and issued with a Test Certificate. A test certificate may be quoted in a type approval certificate, thus reducing the time required to examine an instrument made from test certificated modules and components. The range of modules that can be issued with a Test Certificate include indicators, load cells, printers, POS devices, peripheral devices, and software.
Do non-automatic weighing instruments (NAWI's) used to weigh aircraft to CAA airworthiness requirements need type approval for use in the UK?
The short answer again is not at present. It has been concluded that the 2000 Regulations (SI 2000 No 3236, as amended) would apply to non-automatic weighing instruments (NAWI's) that are used to weigh aircraft where the weighing operation is being carried out to meet requirements laid down in legislation - but not where the aircraft is weighed for other reasons.
Schedule 3 to the 2000 Regulations lists the areas in which the Regulations apply; including 'determination of mass for the applications of laws or regulations including expert opinions given in court proceedings'. It does appear that the Civil Aviation Authority (CAA) checks on the airworthiness of aircraft, carried out under the Civil Aviation Act 1982 and the Air Navigation Order 1989, would require aircraft to be weighed. Given this requirement, it is considered that a court would most probably find that the weighing of aircraft would fall under the scope of the Regulations (ultimately the application would be for the courts to determine).
This means that after 31 December 2002, new, but not existing, instruments that would be used for these purposes will need to be Type Approved.
Who do I contact with questions or queries about non-automatic weighing instruments (NAWI's) type approvals granted by other notified bodies?
NMO does not keep any technical information relating to non-automatic weighing instruments (NAWI's) Type Approved by other Notified Bodies within the EU. Therefore any questions or queries should be directed to the Notified Body who issued the approval.
Can I connect a PC to my weighbridge to produce invoices etc.?
There are requirements that have to be met before a non-verified PC can be connected to an approved and verified weighbridge.
The first requirement is that the indicator of the weighbridge must have an approved interface to allow connection to the PC.
The second requirement is that a Tally Roll printer or a Data Storage Device (DSD) must be connected to the indicator as laid down in the Type Approval Certificate. The indicator should generate a unique number for each weighing which should be stored on the DSD or printed on the Tally Roll printer together with the weighing result.
Any invoice or weight related ticket issued by the non-verified PC should quote the unique number together with the weigh value so there is traceability back to the original weighing in the case of disputes.
Full details of the requirements for DSDs and the requirements for the security of software and data stored are contained in WELMEC Guides 2.3 and 2.5 which can be found on the WELMEC website at www.welmec.org
Should weighing instruments used in pharmacies in the UK only indicate in metric units of weight under legislation covering the sale of drugs or do they have dispensation until 1 January 2003 under the transitional arrangements of directive 90/384/EEC ?
Weighing instruments used in pharmacies, irrespective of whether or not they are in use for trade, should indicate in metric units as they are in use for at least one of the specified circumstances, i.e. economic, public health, public safety or administrative purposes, identified in the Units of Measurement Regulations 1986 (SI 1986/1082 as amended).
The 1 January 2003 has no relevance in relation to the use of metric indications, as this date solely refers to transitional arrangements for both UK approved instruments and instruments not currently subject to control in the UK included within the scope of Schedule 3 to the Non-automatic Weighing Instruments Regulations 2000 (SI 2000 No. 3236).
I am a trading standards officer and I have seen a non-automatic weighing instrument (NAWI) in a local supermarket without a full set of conformity markings. The CE marking and the "Green M" sticker were present but the identification number of the Notified Body verifying the instrument was apparently missing. The weighing instrument was manufactured by Bizerba-Werke in Germany.
On weighing instruments manufactured by Bizerba, the identification number for the Notified Body carrying out the verification is included on the rating plate as a four digit number. However there is no descriptor with the number to inform people what it represents. Bizerba have been contacted and have admitted they get one call a week on this matter!
For further information on the placing of conformity markings, see document WELMEC 2.7 "Directive 90/384/EEC: Explanations and Interpretations".
Do NAWIs used in pharmacies in the UK (including hospital pharmacies) need to be type approved designs?
The Non-automatic Weighing Instruments Regulations 2000 (SI 2000 No. 3236, as amended), which implements Council Directive 90/384/EEC (as amended by Council Directive 93/68/EEC) into UK law, will from 1 January 2003 apply to a number of non-automatic weighing instruments which are presently covered by other regulations, and will also apply to some non-automatic weighing instruments for which there is at present no legislative provision.
This change takes effect because of transitional arrangements provided within the above Regulations, which reflect the derogation in Article 15.3 of the Directive, which provides that instruments conforming to "the rules in force" before 1 January 1993 could continue to be placed on the market and put into service in a Member State for a period of ten years from that date. However, the ten year derogation period ends on 31 December 2002 , and all non-automatic weighing instruments used for any of the purposes listed at Schedule 3 to the above Regulations will need to comply with the essential requirements of the Regulations (see Schedule 2 to the Regulations), from 1 January 2003.
Examples of applications covered by the list at Schedule 3 to the Regulations for which there was no weights and measures legislation in force at the start of the derogation period include: weighing in medical practice, statutory weighing of aircraft, weighing for forensic science, and some weighbridges used solely for the weighing of outgoing lorries at ferry terminals. However, any new instruments used for these and any other Schedule 3 purpose will need to meet the legal controls from 1 January 2003.
The derogation allowed instruments made to a pattern which existed before 1 January 1993 to be initially verified until the expiry of the pattern approval certificate; which cannot in any case be later than 31 December 2002, as approvals are only granted for up to 10 years. Note, however, that expiry of a certificate does not prevent (under EC legislation) subsequent verification or (under national legislation) re-testing and re-stamping of the instrument involved.
What competencies and knowledge do persons operating public weighbridges require?
Sections 18 to 20 of the Weights and Measures Act 1985 requires that persons attending public weighbridges should be competent and have a certificate issued by a Chief Inspector of Weights and Measures showing that they have sufficient knowledge for the proper performance of their duties.
In order to set common standards for the knowledge required by operators of public weighbridges, a guidance document for weights and measures authorities (SWM 258) was prepared and issued in April 1965. This document has since been revised and was re-issued in January 2001 (WM 573).
This guidance document lays down the testing procedures and the amount of knowledge that an applicant for a certificate should possess and provides subject matter for the tests and a model form of the Certificate.
I have seen a verified non-automatic weighing instrument with the notified number shown with only three digits. Is this correct?
All Notified Body numbers have four digits. However, if the first digit is a zero (i.e. 0123) then the leading zero is sometimes omitted.
The non automatic weighing instrument (NAWI) used for trade on the delicatessen counter of a local supermarket has to be washed down daily using a caustic solution. This continual cleaning has removed the notified body number from the verification sticker. What should I do about this?
If the number of the Notified Body responsible for carrying out the initial verification has been removed for whatever reason, then the instrument does not continue to meet the requirements of Regulations 11 and 18 of The Non-automatic Weighing Instruments Regulations 2000 and must be brought back into compliance.
Where the user is aware of the original Notified Body number then the Notified Body should be contacted and arrangements made for a new sticker to be placed on the instrument. However, where this is not possible, then the instrument should be re-qualified (following disqualification under Regulation 24) in accordance with Regulation 11(7) and the number of the Notified Body conducting the re-qualification should be placed on the instrument along with the re-qualification sticker.
In order to prevent the destruction of the verification stickers due to the cleaning requirements of food hygiene regulations, consideration should be given to coating the stickers after application with a clear substance such as varnish or lacquer.
Can a TSO still use imperial weights to test a non-automatic weighing instrument using pounds and ounces, either on inspection or with a view to re-passing it as fit for use for trade and stamping it (for example, after repair)?
No. Whether on inspection or with a view to re-passing it as fit for use for trade and stamping the TSO must use standard weights (either local standards or working standards) or test weights to test the instrument. This is set out in regulation 34 of SI 2000/932, which applies to instruments bearing the Crown stamp (the SI consolidates SI 1988/876 with all subsequent amendments - it comes into force on 2 May 2000 and makes no changes to the law). It is alternatively set out in regulation 8 of SI 1995/1907, which applies to instruments with the green M sticker under Directive 90/384/EEC.
In general standard weights must be from the list in Schedule 3 to the Weights and Measures Act 1985 (see section 5 of that Act). The avoir pound and ounce weights ceased to be in that Schedule as from 1 January 2000 by virtue of regulation 4 of SI 1994/2866.
The limits of error for imperial standard weights and also imperial test weights in SI 1986/1685 were removed by the amendments in Part III of SI 1994/1851, again as from 1 January 2000.
Therefore there are no valid imperial weights now available to test imperial instruments.
Where should the re-qualification sticker be placed on an instrument?
The re-qualification sticker should be affixed so that it is clearly visible when the instrument is in its regular operating position and obliterates as far as possible any disqualification sticker (see the Non-automatic Weighing Instruments Regulations 2000, Reg. 18-(9)). In other words, if there is a disqualification sticker on the instrument, then the re-qualification sticker should be placed over the disqualification sticker. If there is no disqualification sticker, then the re-qualification sticker is placed in the "clearly visible" location where a disqualification sticker would have been placed if one had been present. Should the instrument be subsequently disqualified, the disqualification sticker should be placed over the re-qualification sticker and so on (see also The Non-automatic Weighing Instruments Regulations 2000, Notes for Guidance). For further information on the placing of conformity markings, see document WELMEC 2.7 "Directive 90/384/EEC: Explanations and Interpretations".
What is the situation where a hospital bed has both weighing and other medical functions? Which directives apply?
Council Directive 90/384/EEC covers non-automatic weighing instruments (NAWIs). In that Directive Article 1.2(a) indent 4 requires instruments used for the purposes stated therein to meet the essential requirements through one or other of the appropriate conformity assessment procedures, eg EC type examination followed by EC verification. Indent 4 covers: " determination of mass in the practice of medicine for the weighing of patients for the purposes of monitoring, diagnosis and medical treatment ". This includes activities where medical staff are responsible for the weighing of patients. Examples are the use of weighing instruments in hospitals, health centres or taken into the community for medical purposes. Medical staff includes all persons that lawfully carry out the medical weighing tasks concerned in their Member State. There is some comment about the scope of the Directive in "WELMEC 2.7" which was prepared by the Directorate-General Industry of the European Commission, in collaboration with WELMEC Working Group 2, and which is available on the WELMEC website: www.welmec.org .
Transitional arrangements defer the date on which the provisions become mandatory to 31 December 2002.
NMO has been alerting various organisations, including those in the health service (public and private), to the changes that will apply after 31 December 2002. It is important for them to be aware in good time that a degree of regulation would apply in their area, which had not previously been subject to regulation. All instruments in use as at 31 December 2002 may continue in use indefinitely. But instruments placed on the market after that date will need to comply with the Directive. NMO is aware that NAWIs, used for indent 4 purposes, also have to meet the requirements of the Medical Devices Directive 93/42/EEC. NMO does not have any authoritative advice that enables the requirements of Directive 90/384/EEC to be disregarded, where an instrument is subject to the provisions of the Medical Devices Directive. In that latter Directive, in Article 1.6, there is specific exemption to prevent an overlap with the Directive on personal protective equipment. Given that Directive 90/384/EEC had been out for about three years at the time of the adoption of the Medical Devices Directive, this latter could have included another similar exemption, but did not.
The matter has been discussed from time to time with the Commission, but with no final result. There is also no assistance in the Commission's "Guide to the implementation of Directives based on the new approach and the global approach", which was published in 2000 and which is available from the Commission's website http://europa.eu.int/comm/enterprise/newapproach/legislation.htm.
NMO's conclusion is therefore that an item, which falls within the scope of both Directives, will have to meet the requirements of both Directives. Other Directives may also apply depending on the circumstances, eg EMC electromagnetic compatibility.
Update -Changes to UK Weighing Legislation from 1 January 2003 (PDF, 1.5 Mb)
What is the significance of the date of 1 January 2003 under Directive 90/384/EEC on non-automatic weighing instruments?
Update -Changes to UK Weighing Legislation from 1 January 2003 (PDF, 1.5 Mb)
The Directive contains a ten-year transitional period before all of its provisions bite. NWML has circulated information on the following lines to explain the situation.
The information that follows is important. It may relate to weighing equipment you use.
From 1 January 2003, the Non-Automatic Weighing Instruments Regulations 2000 may apply to non-automatic weighing instruments that you use. From that date, where instruments are brought into use for any of the purposes in the attached list, you will need to ensure that the instruments meet the requirements of the Regulations. A non-automatic weighing instrument is one where an operator is involved in some part of the weighing process.
Will I be affected?
In order to determine whether you will be affected, you simply need to answer the following two questions:
i) will the instrument be used for one of the purposes detailed in the attached list?
ii) will the instrument be first brought into use after 31 December 2002?
If the answer to both of these questions is yes, then the Regulations will apply to your instrument. You may wish to seek your own legal advice, if there is any doubt as to whether the Regulations would apply.
If the regulations apply to me, what will I need to do?
You will need to ensure that any instruments you purchase after 31 December 2002 comply with the requirements of the Regulations. Perhaps the simplest way for you to do this is to ask the instrument's supplier to confirm that it meets the requirements of the above Regulations, and that it bears the necessary symbols, which are:
i) the 'CE' marking;
ii) the 'M' (black 'M' on a green background); and
iii) a four digit number (the identification number of one of several bodies who are authorised to test instruments and confirm that they accord with the Directive on which the Regulations are based).
Does this affect instruments which were brought into use prior to the deadline?
No it does not. You will be able to continue to use any instruments that you have had in use prior to 1 January 2003; and they will not be affected by this change. However, you should note that such instruments may be subject to the requirements of other Regulations.
Where can I obtain copies of the Regulations/further information?
You can obtain a copy of the Regulations from The Office of Public Sector Information. The reference number for the Regulations is: statutory instrument number S.I. 2000/3236. The Regulations can be found on the UK Legislation website.
Notes for guidance on the regulations have also been written, and may be viewed in our Notes for Guidance, within the 'Information' section.
You may also wish to contact the Trading Standards Department within your Local Authority for advice. Trading Standards Officers are responsible for enforcing many of the requirements within the Regulations.
I work for the Crown, are my instruments exempt?
No, not in this case. Any recipients who are working for the Crown, for example as a member of HM Forces, will wish to note that, because these Regulations derive from a European Directive, the Crown is not exempt from their requirements.
Could you reiterate the change in simple terms?
Yes. Previous recipients of information about this change have commented that they have found it to be very complicated. We have therefore revised this letter, to keep it very simple. I will therefore reiterate the single message of this letter: the above Regulations will apply to non-automatic weighing instruments which are brought into use after 31 December 2002 for any of the purposes in the attached list. Instruments already in use are unaffected by this change.
You may wish to disseminate this to others within your organisation, or to your contacts who may have an interest.
The Non-automatic Weighing Instruments Regulations 2000 will apply to non-automatic weighing instruments (that are brought into use after 31 December 2002) used for the following purposes:
1. Determination of mass for commercial transactions, which deals with trading transactions where the goods are bought or sold by mass. The cost therefore is directly proportional to the mass of the product. For example: weighing of fruit in a greengrocers, or using a weighbridge in connection with a commercial transaction.
2. Determination of mass for the calculation of a toll, tariff, tax, bonus, penalty, remuneration, indemnity or similar type of payment. This type of use not only includes situations where the payment is directly proportional to the mass, e.g. remuneration, tax etc. but also situations where the mass value determines the cost of the service, e.g. post office use, laundry or airport baggage tariff, charge for transporting goods, disposal of waste.
3. Determination of mass for the application of laws or regulations including expert opinions given in court proceedings, which covers the activities where an instrument is used by a person who is not an expert in metrology but is giving evidence based on weighing results. Instruments used for the same purposes by experts from metrological laboratories, government or public authority laboratories and forensic laboratories are therefore excluded on the condition that such laboratories keep their instruments properly maintained, calibrated and adjusted. This might however include, for instance: the weighing of aircraft in connection with statutory requirements, or the weighing of vehicles in connection with statutory weight restrictions.
4. Determination of mass in the practice of medicine for weighing patients for the purpose of monitoring, diagnosis and medical treatment, which covers those activities where medical staff are responsible for the weighing of patients. Examples are the use of weighing instruments in hospitals, health centres or taken into the community for medical purposes. Medical staff includes all persons that lawfully carry out the medical weighing tasks concerned in their Member State. Medical weighing tasks might include, for example, bed-weighers and baby-weighers.
Also see:
5. Determination of mass for making up medicines on prescription in a pharmacy and determination of mass in analyses carried out in medical and pharmaceutical laboratories, where medical laboratories are laboratories that carry out analyses at the request of medical practitioners and pharmaceutical laboratories are quality control laboratories of manufacturers of medicinal products for human use. Pharmaceutical laboratories do not include the research and development laboratories of manufacturers of these medicinal products.
6. Determination of price on the basis of mass for the purposes of direct sales to the public and the making up of pre-packages The former case covers the use of instruments with price calculation, in particular price-calculating retail scales, and the latter refers to scales used to make up pre-weighed non-predetermined quantities. Please note that the applications as listed by the Regulations are in bold, whilst the additional information, which is intended to guide you, is not bold. Please note that you may need to seek your own legal advice as to whether your particular application does fall within one of these categories.
Update - changes to UK weighing legislation from 1 January 2003 (PDF, 1.5 Mb)
How should a non-automatic weighing instruments that fails an inspection be disqualified?
The correct method for disqualification of a non-automatic weighing machine is to use a disqualification sticker placed close to the other prescribed markings on the machine. The form of the sticker is published in the guidance to the regulations and reproduced on the NMO website. Read NAWI Notes for guidance. The number of the notified body that conducted the conformity assessment tasks (initial verification) should remain on the machine throughout its life.
