- Status
- In Force
- Penalty ceiling
- Regulated
Does it bind you?
Business-side roles with duties under this instrument.
Manufacturer30
Conformity Assessment Body18
Distributor6
Operator3
Plus 10 duties on the regulator, Crown ministers and public bodies — folded into the section list below.
Other Acts binding the same actors
If a role above is yours, these are the other instruments that most often bind it.
Manufacturer — also bound by 502 other Acts
Measuring Instruments Regulations 2016
85 duties
Human Medicines Regulations 2012
75 duties
Conformity Assessment Body — also bound by 47 other Acts
Lifts Regulations 2016
28 duties
Radio Equipment Regulations 2017
27 duties
Explosives Regulations 2014
22 duties
Distributor — also bound by 182 other Acts
UK REACH Regulation (retained EU law)
44 duties
Operator — also bound by 746 other Acts
Regulation (EU) No 965/2012 (Air Operations)
203 duties
Space Industry Regulations 2021
76 duties
What it requires
Regulations creating concrete business duties or carrying penalties, grouped as the instrument is structured. Titles link to the source text — blue means you’re leaving for legislation.gov.uk.
s.005
Design and manufacture in accordance with essential health and safety requirements
Regulated
- Ensure product design and manufacture meet essential safety requirementsManufacturer
s.006
Technical documentation and conformity assessment
Regulated
- Carry out conformity assessment and prepare technical documentation before placing ATEX products on the marketManufacturer
s.007
EU declaration of conformity and CE marking
Regulated
- You must draw up an EU declaration of conformity and affix CE marking before placing product on marketManufacturer
s.008
Retention of technical documentation and EU declaration of conformity
Regulated
- Keep technical documentation and declaration of conformity for 10 yearsManufacturer
s.009
Compliance procedures for series production
Regulated
- Put procedures in place for series production conformityManufacturer
s.010
Monitoring
Regulated
- Monitor product safety, investigate complaints and keep registersManufacturer
s.011
Labelling and packaging of products
Regulated
- Label products with identification number before placing on marketManufacturer
s.012
Labelling and packaging of products, other than components
Regulated
- Apply explosion protection marking to products before placing on marketManufacturer
s.013
Information identifying manufacturer
Regulated
- Label products with manufacturer name and contact addressManufacturer
s.014
Instructions and safety information
Regulated
- Provide instructions and safety info in easily understood languageManufacturer
s.015
Duty to take action in respect of a product placed on the market which is considered not to be in conformity
Regulated
- Correct non-conforming products and notify authorities if risk presentManufacturer
s.016
Provision of information and cooperation
Regulated
- Provide information and cooperate with market surveillance authority on requestManufacturer
s.017
Authorised representatives
Regulated
- Appoint an authorised representative in the EU/EEA by written mandateManufacturer
s.018
Prohibition on placing on the market products which are not in conformity
Regulated
- Do not place non-conforming products on the marketManufacturer
s.019
Requirements which shall be satisfied before an importer places a product on the market
Regulated
- Check manufacturer compliance before importing and selling products for explosive atmospheresManufacturer
s.020
Prohibition on placing on the market products considered not to be in conformity with the essential health and safety requirements
Regulated
- Do not place non-conforming products on the market and report risksManufacturer
s.021
Information identifying importer
Regulated
- Label imported equipment with importer's name and contact addressManufacturer
s.022
Instructions and safety information
Regulated
- Provide instructions and safety information in a language end-users understandManufacturer
s.023
Storage and transport
Regulated
- Ensure storage and transport conditions do not affect product safety conformityManufacturer
s.024
Monitoring
Regulated
- Monitor products and keep records of non-conformance and recallsManufacturer
s.025
Duty to take action in respect of a product placed on the market which is considered not to be in conformity
Regulated
- Take corrective action if you place non-compliant explosive-atmosphere equipment on the marketManufacturer
s.026
Provision of information and cooperation
Regulated
- Provide information and cooperate with the market surveillance authority on requestManufacturer
s.027
Retention of technical documentation and EU declaration of conformity
Regulated
- Keep technical documentation and EU declaration for 10 yearsManufacturer
s.028
Duty to act with due care
Regulated
- Act with due care when making products available on the marketDistributor
s.029
Requirements which shall be satisfied before a distributor makes a product available on the market
Regulated
- Verify product conformity and documentation before placing on the marketDistributor
s.030
Storage and transport
Regulated
- Ensure storage and transport conditions maintain product safety conformityDistributor
s.031
Prohibition on making available on the market where product not considered to be in conformity with safety objectives
Regulated
- Do not place non-conforming products on the market and notify if riskDistributor
s.032
Duty to take action in respect of products made available on the market which are not in conformity
Regulated
- Take corrective action for non-conforming products and notify authorities of riskDistributor
s.033
Provision of information and cooperation
Regulated
- Provide information and cooperate with market surveillance authorityDistributor
s.035
Identification of economic operators
Regulated
- Identify your product supply chain to the market surveillance authority on requestOperator
s.036
Prohibition on improper use of CE marking
Regulated
- Don't misuse the CE marking or misleading marksOperator
s.037
Translation of declaration of conformity
Regulated
- Translate EU declaration of conformity into English for Northern Ireland marketOperator
s.039
Conformity assessment procedures
Regulated
- You must follow the correct conformity assessment procedure for your equipment categoryManufacturer
s.041
UK(NI) indication
Regulated
- Affix UK(NI) indication alongside CE marking on equipment for explosive atmospheresManufacturer
s.048
Changes to notifications
Regulated
- Notified body must transfer or retain files if status lost or activity ceasedConformity Assessment Body
s.050
Subsidiaries and contractors
Regulated
- Notified bodies must control subcontractors and subsidiariesConformity Assessment Body
s.056
Enforcement action in respect of products which are not in conformity and which present a risk
Regulated
Other duties (1) — Crown / regulator
- Executive must enforce corrective action for non-conforming explosive atmosphere productsStatutory regulator
s.058
Enforcement action in respect of products which are in conformity, but present a risk
Regulated
Other duties (1) — Crown / regulator
- Executive must order risk mitigation or removal of compliant productsStatutory regulator
37 other provisions — procedural and definitional
s.001
Citation and commencement
s.002
Interpretation
s.003
Scope
s.004
Exceptions for trade fairs, exhibitions and demonstrations
s.034
Cases in which obligations of manufacturers apply to importers and distributors
s.038
Presumption of conformity
s.040
EU declaration of conformity
s.041
CE marking
s.041
Register of notified bodies established in the United Kingdom
s.042
Notified bodies
s.043
Presumption of conformity of notified bodies
s.044
Notification
s.045
Contents of notification
s.046
Monitoring
s.047
United Kingdom Accreditation Service
s.049
Operational obligations of notified bodies
s.051
Designation of market surveillance authority
s.052
Enforcement
s.053
Enforcement powers
s.054
Exercise of enforcement powers
s.055
Evaluation of a product presenting a risk
s.057
EU safeguard procedure
s.059
Enforcement action in respect of formal non-compliance
s.060
Restrictive measures
s.061
Offences
s.062
Penalties
s.063
Defence of due diligence
s.064
Liability of persons other than principal offender
s.065
Time limit for prosecution of offences
s.066
Service of documents
s.067
Recovery of expenses of enforcement
s.068
Action by the Executive
s.069
Appeals against notices
s.070
Appropriate court for appeals against notices
s.071
Transitional provisions
s.071
Transitional provision in relation to notification of conformity assessment bodies
s.072
Consequential amendments, revocations and savings
Schedules
Schedules
29 of 89 shown
s.sch001
Principles of integrated explosion safety
Regulated
- Design equipment to prevent explosions and limit their effectsManufacturer
s.sch001
Requirements applicable to equipment in category M 1 of equipment-group I
Regulated
- Design and construct Category M1 equipment to prevent ignition in explosive atmospheresManufacturer
s.sch001
Requirements applicable to equipment in category M 2 of equipment-group I
Regulated
- Ensure explosive atmosphere protection for Category M 2 equipmentManufacturer
s.sch001
Explosive atmospheres caused by gases, vapours or mists
Regulated
- Design and construct explosion-proof equipment for gas atmospheresManufacturer
s.sch001
Explosive atmospheres caused by gases, vapours or mists
Regulated
- Design and construct equipment to prevent ignition in explosive atmospheresManufacturer
s.sch002
A conformity assessment body shall have— (a) personnel with technical...
Regulated
- Have qualified personnel and documented procedures for conformity assessmentConformity Assessment Body
s.sch002
A conformity assessment body shall have the means necessary to...
Regulated
- Ensure your conformity assessment body has necessary resources and equipmentConformity Assessment Body
s.sch002
A conformity assessment body shall be able to demonstrate the...
Regulated
- Conformity assessment body must prove impartiality of management and staffConformity Assessment Body
s.sch002
A conformity assessment body shall have, and shall satisfy the...
Regulated
- Maintain adequate civil liability insurance for conformity assessment activitiesConformity Assessment Body
s.sch002
A conformity assessment body shall ensure that its personnel observe...
Regulated
- Ensure personnel keep information confidential and protect proprietary rightsConformity Assessment Body
s.sch002
A conformity assessment body shall participate in, or ensure that...
Regulated
- Keep informed of standardisation activities and apply coordination group guidanceConformity Assessment Body
s.sch002
(1) A conformity assessment body, its top level management and...
Regulated
- Conformity assessment bodies must stay independent — cannot design, make or sell the products they assessConformity Assessment Body
s.sch002
A conformity assessment body, its top level management and the...
Regulated
- Stay independent — do not design, make, sell or maintain products you assessConformity Assessment Body
s.sch002
A conformity assessment body, its top level management and the...
Regulated
- Avoid conflicts of interest in conformity assessment activitiesConformity Assessment Body
s.sch002
A conformity assessment body shall ensure that the activities of...
Regulated
- Ensure subsidiaries and subcontractors maintain confidentiality, objectivity and impartialityConformity Assessment Body
s.sch002
A conformity assessment body and its personnel shall carry out...
Regulated
- Conformity assessment bodies must act with integrity and technical competenceConformity Assessment Body
s.sch002
A conformity assessment body shall be capable of carrying out...
Regulated
- Be able to carry out all notified conformity assessment activitiesConformity Assessment Body
s.sch003
A notified body shall carry out conformity assessments in accordance...
Regulated
- Notified bodies must follow correct conformity assessment proceduresConformity Assessment Body
s.sch003
A notified body shall inform the Executive of—
Regulated
Other duties (1) — Crown / regulator
- Notified bodies must report certificate actions and scope changes to the ExecutiveStatutory regulator
s.sch003
A notified body shall make provision in its contracts with...
Regulated
- Notified bodies must include appeal rights in client contractsConformity Assessment Body
s.sch003
A notified body shall provide other bodies notified under the...
Regulated
- Share conformity assessment results with other notified bodiesConformity Assessment Body
s.sch003
A notified body shall participate in the work of any...
Regulated
- Participate in the ATEX notified body coordination groupConformity Assessment Body
s.sch003
A notified body shall— (a) acknowledge receipt of the technical...
Regulated
Other duties (1) — Crown / regulator
- Notified body must acknowledge receipt of technical documentation and retain itStatutory regulator
s.sch003
A notified body shall carry out conformity assessments in a...
Regulated
Other duties (1) — Crown / regulator
- Notified bodies must assess proportionately and avoid unnecessary burdensStatutory regulator
s.sch003
A notified body shall perform its activities taking due account...
Regulated
Other duties (1) — Crown / regulator
- Notified bodies must tailor assessments to your business sizeStatutory regulator
s.sch003
A notified body shall respect the degree of rigour and...
Regulated
Other duties (1) — Crown / regulator
- Notified body must apply appropriate rigour and protection level in conformity assessmentsStatutory regulator
s.sch003
Where, in the course of the monitoring of conformity following...
Regulated
Other duties (1) — Crown / regulator
- Notified body must enforce corrective measures and suspend or withdraw certificates for non‑conforming productsStatutory regulator
s.sch003
Where the notified body has required a manufacturer to take...
Regulated
Other duties (1) — Crown / regulator
- Notified body must restrict, suspend or withdraw certificates when corrective measures failStatutory regulator
s.sch003
Where this paragraph applies, the notified body shall—
Regulated
Other duties (1) — Crown / regulator
- Notified body must give notice and right of reply before refusing, suspending or withdrawing a certificate or approvalStatutory regulator
60 other schedules
s.sch001
Preliminary observations
s.sch001
Dust deposits
s.sch001
Additional means of protection
s.sch001
Safe opening
s.sch001
Protection against other hazards
s.sch001
Overloading of equipment
s.sch001
Flameproof enclosure systems
s.sch001
Hazards arising from different ignition sources
s.sch001
Hazards arising from static electricity
s.sch001
Hazards arising from stray electric and leakage currents
s.sch001
Hazards arising from overheating
s.sch001
Hazards arising from pressure compensation operations
s.sch001
Hazards arising from external effects
s.sch001
Requirements in respect of safety-related devices
s.sch001
Control and display units
s.sch001
Requirements in respect of devices with a measuring function for explosion protection
s.sch001
Risks arising from software
s.sch001
Integration of safety requirements relating to the system
s.sch001
Hazards arising from power failure
s.sch001
Hazards arising from connections
s.sch001
Placing of warning devices as parts of equipment
s.sch001
Special checking and maintenance conditions
s.sch001
Explosive atmospheres caused by air and dust mixtures
s.sch001
Explosive atmospheres caused by air and dust mixtures
s.sch001
Explosive atmospheres caused by gases, vapours or mists
s.sch001
Explosive atmospheres caused by air and dust mixtures
s.sch001
General requirements
s.sch001
Characteristics of materials
s.sch001
Surrounding area conditions
s.sch001
Pressure-relief systems
s.sch001
Explosion suppression systems
s.sch001
Explosion decoupling systems
s.sch001
Protective systems shall be capable of being integrated into a...
s.sch001
Marking
s.sch001
Instructions
s.sch001
Selection of materials
s.sch001
Design and construction
s.sch001
Enclosed structures and prevention of leaks
s.sch002
A conformity assessment body shall be established in the United...
s.sch002
The personnel responsible for carrying out conformity assessment activities shall...
s.sch002
The remuneration of the top level management and the personnel...
s.sch002
Paragraph 16 does not prevent the personnel from providing information...
s.sch002
A conformity assessment body shall be a third party body...
s.sch002
A body belonging to a business association or professional federation...
s.sch003
Where a notified body finds that essential health and safety...
s.sch003
Paragraph 9 applies where a notified body is minded to—...
s.sch004
Enforcement powers under the 1978 Order
s.sch004
Modifications to the 1978 Order
s.sch005
Compliance notice
s.sch005
Withdrawal notice
s.sch005
Recall notice
s.sch005
Interpretation
s.sch006
Product model/product (product, type, batch or serial number):
s.sch006
Name and address of manufacturer and, where applicable, the authorised...
s.sch006
This declaration of conformity is issued under the sole responsibility...
s.sch006
Object of the declaration (identification of product allowing traceability; it...
s.sch006
The object of the declaration described above is in conformity...
s.sch006
References to the relevant harmonised standards used or references to...
s.sch006
Where applicable, the notified body (name, number) performed (description of...
s.sch006
Additional information: Signed for and on behalf of: (place and...
Duty extraction and severity labels are Guvnor’s analysis of the instrument, not the instrument itself. Always verify against the linked source text.