CHAPTER IIIF1... MARKET SURVEILLANCE FRAMEWORK AND CONTROLS OF PRODUCTS ENTERING THE F2MARKET OF GREAT BRITAIN
SECTION 1General provisions
Article 15Scope
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For the purposes of Articles 16 to F1122 and 26, a ‘product’ F12means a substance, preparation or good produced through a manufacturing process other than food, feed, living plants and animals, products of human origin and products of plants and animals relating directly to their future reproduction.
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Article 16General requirements
F161.
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Market surveillance F17authorities F18must ensure that products covered by F19any relevant enactment which, when used in accordance with their intended purpose or under conditions which can be reasonably foreseen and when properly installed and maintained, are liable to compromise the health or safety of users, or which otherwise do not conform to applicable requirements set out in F19any relevant enactment are withdrawn or their being made available on the market is prohibited or restricted and that the public F20and the Secretary of State are informed accordingly.
F213.
The Secretary of State must ensure that there is a national market surveillance infrastructure and programme so that effective measures may be taken in relation to any product subject to any relevant enactment.
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SECTION 2F25Market surveillance framework
Article 17Information obligations
F261.
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F27The Secretary of State must take appropriate measures to ensure that the public is aware of the existence, responsibilities and identity of national market surveillance authorities, and of how those authorities may be contacted.
Article 18Obligations F28... as regards organisation
F291.
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2.
F30The Secretary of State must establish adequate procedures in order to:
(a)
follow up complaints or reports on issues relating to risks arising in connection with products subject to F31any relevant enactment;
(b)
monitor accidents and harm to health which are suspected to have been caused by those products;
(c)
verify that corrective action has been taken; and
(d)
follow up scientific and technical knowledge concerning safety issues.
F323.
The Secretary of State may by regulations make such provision as the Secretary of State considers appropriate to ensure that market surveillance authorities have the powers necessary for the proper performance of their duties.
The Secretary of State must entrust market surveillance authorities with the resources and knowledge necessary for the proper performance of their duties.
Regulations made under this paragraph must be made by statutory instrument.
A statutory instrument containing regulations under this paragraph may not be made unless a draft of the instrument has been laid before, and approved by a resolution of, each House of Parliament.
F334.
Market surveillance authorities must exercise their powers proportionately.
F345.
The Secretary of State must establish, implement and periodically update the United Kingdom's market surveillance programme setting out the principles as to how market surveillance is to be organised and covering the sectors in which market surveillance is conducted in the United Kingdom. The Secretary of State must make this programme available to the public by way of electronic communication and, where appropriate, by other means.
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F35The Secretary of State F36must periodically review and assess the functioning of F37... surveillance activities F38by market surveillance authorities. Such reviews and assessments F36must be carried out at least every fourth year and the results thereof F36must F39... be made available to the public, by way of electronic communication and, where appropriate, by other means.
Article 19Market surveillance measures
1.
Market surveillance authorities F40must perform appropriate checks on the characteristics of products on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks on the basis of adequate samples. When doing so they F40must take account of established principles of risk assessment, complaints and other information.
Market surveillance authorities may require economic operators to make such documentation and information available as appear to them to be necessary for the purpose of carrying out their activities, and, where it is necessary and justified, enter the premises of economic operators and take the necessary samples of products. They may destroy or otherwise render inoperable products presenting a serious risk where they deem it necessary.
Where economic operators present test reports or certificates attesting conformity issued by an accredited conformity assessment body, market surveillance authorities F40must take due account of such reports or certificates.
2.
Market surveillance authorities F41must take appropriate measures to alert users F42... within an adequate timeframe of hazards they have identified relating to any product so as to reduce the risk of injury or other damage.
They F41must cooperate with economic operators regarding actions which could prevent or reduce risks caused by products made available by those operators.
F433.
Where a market surveillance authority decides to withdraw a product manufactured in the United Kingdom, it must inform the economic operator concerned at the address indicated on the product in question or in the documentation accompanying the product.
4.
Market surveillance authorities F44must carry out their duties independently, impartially and without bias.
F455.
Market surveillance authorities must observe confidentiality where necessary in order to protect commercial secrets or to preserve personal data pursuant to national legislation, subject to the requirements that:
a)
information be made public under this Regulation to the fullest extent necessary in order to protect the users in the United Kingdom;
b)
the protection of confidentiality shall not prevent the dissemination to market surveillance authorities of information relevant to ensuring the effectiveness of market surveillance activities.
Article 20Products presenting a serious risk
1.
F46Market surveillance authorities must ensure that products which present a serious risk requiring rapid intervention, including a serious risk the effects of which are not immediate, are recalled, withdrawn or that their being made available on F47the market is prohibited, and that the F48Secretary of State is informed without delay thereof, in accordance with Article 22.
2.
The decision whether or not a product represents a serious risk F49must be based on an appropriate risk assessment which takes account of the nature of the hazard and the likelihood of its occurrence. The feasibility of obtaining higher levels of safety or the availability of other products presenting a lesser degree of risk F50does not constitute grounds for considering that a product presents a serious risk.
Article 21Restrictive measures
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Prior to the adoption of a measure referred to in paragraph 1, the economic operator concerned F56must be given the opportunity to be heard within an appropriate period of not less than 10 days, unless such consultation is not possible because of the urgency of the measure to be taken, as justified by health or safety requirements or other grounds relating to the public interests covered by F57any of the relevant enactments. If action has been taken without the operator's being heard, the operator F56must be given the opportunity to be heard as soon as possible and the action taken F56must be reviewed promptly thereafter.
4.
Any measure referred to in paragraph 1 F58must be promptly withdrawn or amended upon the economic operator's demonstrating that he has taken effective action.
Article 22F59Notification of serious risk
F601.
Where a market surveillance authority takes or intends to take a measure in accordance with Article 20 it must immediately notify the Secretary of State of that measure.
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The information provided in accordance with paragraphs 1 and 2 F64must include all available details, in particular the data necessary for the identification of the product, the origin and the supply chain of the product, the related risk, the nature and the duration of the F65... measure taken and any voluntary measures taken by economic operators.
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For the purposes of paragraphs 1, 2 and 3, the market surveillance F66authority must notify the Secretary of State through the database containing information relating to market surveillance and product safety established by regulation 33(A1) of the General Product Safety Regulations 2005.
F67Article 23General information support system
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F67Article 24Principles of cooperation between the Member States and the Commission
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F67Article 25Sharing of resources
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Article 26Cooperation with the competent authorities of third countries
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F702.
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SECTION 3Controls of F71imported products F72...
Article 27F73Controls of imported products
F741.
The authorities in charge of the control of products entering Great Britain must carry out appropriate checks on the characteristics of products on an adequate scale, in accordance with the principles set out in Article 19(1), before those products are discharged from the free-circulation procedure.
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The authorities in charge of external border controls F77must suspend F78the discharge of a product from the free-circulation procedure when any of the following findings are made in the course of the checks referred to in paragraph 1:
(a)
the product displays characteristics which give cause to believe that the product, when properly installed, maintained and used, presents a serious risk to health, safety, the environment or any other public interest referred to in Article 1;
(b)
the product is not accompanied by the written or electronic documentation required by F79any relevant enactment or is not marked in accordance with that legislation;
(c)
F80a conformity marking has been affixed to the product in a false or misleading manner.
The authorities in charge of external border controls F77must immediately notify the market surveillance authorities of any such suspension.
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In the case of perishable products, the authorities in charge of external border controls F81must, as far as possible, seek to ensure that any requirements they may impose with regard to the storage of products or the parking of vehicles used for transport are not incompatible with the preservation of those products.
F825.
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Article 28F83Discharge of products
1.
A product the F84discharge of which has been suspended by the authorities in charge of external border controls pursuant to Article 27 F85must be F86discharged from the free-circulation procedure if, within three working days of the suspension of F84discharge, those authorities have not been notified of any action taken by the market surveillance authorities, and provided that all the other requirements and formalities pertaining to such F84discharge have been fulfilled.
2.
Where the market surveillance authorities find that the product in question does not present a serious risk to health and safety or cannot be regarded as being in breach of F87any relevant enactment, that product F88must be discharged from the free-circulation procedure, provided that all the other requirements and formalities pertaining to such F89discharge have been fulfilled.
Article 29National measures
1.
Where F90a market surveillance authority finds that a product presents a serious risk, F91it F92must take measures to prohibit that product from being placed on the market and F92must require the authorities in charge of external border controls to include the following endorsement on the commercial invoice accompanying the product and on any other relevant accompanying document or, where data processing is carried out electronically, in the data-processing system itself:
‘Dangerous product — F93discharge from the free-circulation procedure not authorised — Regulation (EC) No 765/2008’.
2.
Where F94a market surveillance authority finds that a product does not comply with F95any relevant enactment, F96it F97must take appropriate action, which may, if necessary, include prohibiting the product's being placed on the market.
Where placing on the market is prohibited pursuant to the first subparagraph, the market surveillance F98authority F97must require the authorities in charge of external border controls not to F99discharge the product from the free-circulation procedure and to include the following endorsement on the commercial invoice accompanying the product and on any other relevant accompanying document or, where data processing is carried out electronically, in the data-processing system itself:
‘Product not in conformity — F100discharge from the free-circulation procedure not authorised — Regulation (EC) No 765/2008’.
3.
Where that product is subsequently declared for a customs procedure other than F101the free-circulation procedure and provided that the market surveillance authorities do not object, the endorsements set out in paragraphs 1 and 2 F102must also be included, under the same conditions, on the documents used in connection with that procedure.
4.
F103Market surveillance authorities may destroy or otherwise render inoperable products presenting a serious risk where they deem it necessary and proportionate.
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Market surveillance authorities F104must provide authorities in charge of external border controls with information on product categories in which a serious risk or non-compliance within the meaning of paragraphs 1 and 2 has been identified.