Market Surveillance Due to Import & Marketing
The AOSH monitors that machines, equipment, personal protective equipment and other products that fall within the scope of the administration’s work meet the requirements made of them.
It is not permitted to place on the market or take into use any type of machinery, equipment, personal protective equipment and other devices that do not meet the rules on safety and formal requirements set out in the Act on Working Environment, Health and Safety in Workplaces and regulations issued on the basis thereof. This means that certain products must be CE-marked in order to be put on the Icelandic market.
The AOSH monitors that machinery, equipment, personal protective equipment and other devices meet the essential minimum health and safety requirements and are CE-marked. The surveillance covers personal protective equipment used for work. The Consumer Agency monitors personal protective equipment intended for private use.
It is investigated whether the machine, equipment or personal protective equipment is CE-marked correctly and that the equipment is accompanied by adequate instructions. The surveillance may also involve examining the EU declaration of conformity, which should be accessible in all sales and distribution.
In some cases, there is reason to call for technical documentation from the manufacturer or their agent within the European Economic Area and even to require special testing.
The manufacturer or an authorized representative, such as the importer, is responsible for ensuring that the machine, equipment or personal protective equipment meets the essential health and safety requirements and that all technical documents are available to the AOSH.
The AOSH has the authority to prohibit the marketing of machinery, equipment or personal protective equipment that is not CE-marked or does not meet the requirements made of them. The AOSH also has the authority to temporarily prohibit sales while it is being investigated whether the product in question meets the requirements in question. The manufacturer or an authorized representative in Iceland must then carry out tests at their own expense.
If the product does not meet the requirements, the AOSH requests its withdrawal. Violation of the rules can result in fines.
Regulations on Market Surveillance by the AOSH
The AOSH has been entrusted with market surveillance of machinery, equipment, personal protective equipment and other products covered by the regulations below.
- Portable pressurization equipment, cf. the Regulation on Mobile Pressure Equipment which was set for implementation on Directive no. 2010/35 / EC
- Aerosols, cf. the Regulation on Aerosols which was set for implementation on Directive no. 75/324 / EEC
- Machinery and equipment, cf. the Regulation on Machinery and Technical Equipment which was set for implementation on Directive no. 2006/42 / EC. The Regulation applies to many machines and equipment, for example heavy machinery (excavators, forklifts, etc.), conveyor belts, fish processing machines and chainsaws.
- Passenger lifts and passenger and cargo lifts, cf. the Regulation on Passenger Lifts and Passenger and Cargo Lifts which was set for implementation on Directive no. 2014/33 / EC,
- Cableway equipment, cf. the Regulation on Cableway Equipment for Passenger Transport which was set for implementation on Directive no. 2016/424 / EC,
- Pressure equipment, cf. the Regulation on Pressure Equipment which was set for implementation on Directive no. 2014/68 / EC,
- Appliances that burn gas, cf. the Regulation for Appliances Burning Gas which was set for implementation on Directive no. 2016/426 / EC,
- Mass-produced simple pressure cartridges, cf. rules on simple pressure cartridges which was set for implementation on Directive no. 2014/29 / EC,
- Combustion engines of portable off-road machines, cf. the Regulation on the Type Approval of Combustion Engines, the Emission Limits of Pollutant Gases and More which was set for implementation on Directive no. 2016/1628 / EC,
- Personal protective equipment, cf. the Regulation on the Structure of Personal Protective Equipment which was set for implementation on Directive no. 2016/425 / EC,
- Explosives, cf. the Regulation on Explosives and Precursors for Explosives Production which was set for implementation on Directive no. 2014/25 / EC and Directive no. 2014/28 / EC,
- Machines, cf. the Regulation on Noise Pollution in the Environment Caused by Equipment for Outdoor Use, which was set for implementation on Directive no. 2000/14 / EC.
The CE-marking indicates that the manufacturer, importer or distributor of a product guarantees that it meets the essential requirements for safety and general health. These are requirements that are standardized in the internal market of the European Economic Area and are based on EU directives on the product concerned. However, the CE-marking does not indicate the quality or durability of the product. Only that it meets the aforementioned basic requirements.
In order for a product to have the CE-marking, the manufacturer’s declaration of conformity must be available. It is based on a risk and conformity assessment, which involves assessing whether the product in question conforms to and complies with the provisions of the relevant regulations and standards that apply to it.
The CE-marking has sometimes been likened to a product passport, as CE-marking have free flow across borders within the EEA/EU.
Responsibility of Manufacturers and Importers
The manufacturer and their authorized representative, e.g. importer are solely responsible for the safety of the product and that it is CE-marked.
In most cases, it is sufficient that the manufacturer and their authorized
representative presents EU declaration of conformity for certifying the
conformity of the product to confirm that the product complies with the relevant requirements, following a risk and conformity assessment. The manufacturer and their authorized representative should prepare
a technical construction file which must be available on request and which demonstrates conformity of the product with the essential health and safety requirements.
Sometimes, however, further steps must be taken. For example, in the case of dangerous machinery, in which case a notified body may need to be consulted in accordance with Annex IV to the Regulation on Machinery and Technical Equipment.
The manufacturer or an authorized representative, such as the importer, is responsible for ensuring that the machine, equipment or personal protective equipment meets the essential health and safety requirements and that all technical documents are available to the AOSH. Also that the product is CE-marked, otherwise the AOSH has the authority to prohibit marketing and their use. Therefore, it is important for the importer to familiarize themselves with the rules that apply to the product in Iceland before it is imported into the country.
It is important that all applicable information is presented in EU declaration of conformity according to the regulation while the AOSH has no legal permission to grant an exemption there of.
Machinery, Equipment and CE-markings
Manufacturers of machinery and equipment in Iceland must have their products CE-marked, regardless of whether they are to be exported to other Member States within the European Economic Area or solely to be marketed or used in Iceland.
The CE-marking process according to the Regulation on Machinery and Technical Equipment involves carrying out risk assessment and conformity assessment. When this is done, a declaration of conformity is issued and the product can be CE-marked.
The risk assessment can be performed in various ways, but the most convenient is to based it on the ÍST EN ISO 12100 standard. The standard is an accessible tool for making risk assessments and guides the person in question through it. It, as well as other standards, can be accessed at the website of the Standards Council.
The conformity assessment involves assessing whether the product in question conforms to and complies with the provisions of the relevant regulations and standards that apply to it. In the case of machinery and equipment, the essential health and safety requirements are defined in Annex I to the Regulation on Machinery and Technical Equipment, in addition to being defined in standards. Other regulations may also need to be taken into account in the conformity assessment. For example, regarding the finishing of electrical equipment or pressurizing equipment.
The AOSH and the Icelandic Standards Council hold regular courses regarding CE-marking of machinery and equipment. More information about them can be found at the website of the Standards Council.
CE-marking of Personal Protective Equipment
A personal protective equipment is any equipment or device worn or held by an individual to protect against a hazard or hazards that may endanger their health or safety.
Standardized rules apply within the European Economic Area to personal protective equipment, whether for professional or personal use. The rules stipulate certain minimum safety requirements that personal protective equipment must meet. The personal protective equipment is CE-marked when the requirements are met.
The main content of the rules is that:
- Personal protective equipment meets the essentail requirements for health and safety
- Personal protective equipment must be CE-marked
- Personal protective equipment must be accompanied by instructions in Icelandic
- Manufacturers or an authorized representative within the European Economic Area shall issue an EU declaration of conformity for each type of personal protective equipment put on the market.
The manufacturer of personal protective equipment must take great care that the protective equipment complies with the rules in question before starting production.
It is not permitted to import, sell and use personal protective equipment in Iceland other than those that are CE-marked. Therefore, care must be taken to ensure that personal protective equipment that is to be purchased, imported into the country or used is CE-marked.
The AOSH monitors that personal protective equipment is CE-marked and meets the minimum requirements that apply to it.
When a manufacturer or importer intends to market personal protective equipment in Iceland, they must comply with the regulations on the type of personal protective equipment.
It is important that the personal protective equipment meets all the requirements set out therein and is CE-marked.
- Rules no. 501/1994 aboutReglurnar gilda um persónuhlífar sem settar voru á markað fyrir 25. júlí 2018 nema annað leiði af ákvæðum reglugerðar nr. 728/2018 um gerð persónuhlífa.
The CE-marking confirms that the product meets the essential health and safety requirements in accordance with the Regulation. It must be on each piece of personal protective equipment so that it is indelible.
When this is not possible due to the properties of the protective equipment, the marking can be placed on its packaging. Other markings must not cause misunderstanding or obscure the CE-marking.
The manufacturer is responsible for ensuring that conformity assessment is carried out and that all technical documents are compiled and preserved. Sometimes the manufacturer has to seek the approval of a notified body for type testing, certification and quality system control. Once the conformity assessment is available, the manufacturer can prepare and issue a declaration of conformity for the personal protective equipment.
With a declaration of conformity, the manufacturer certifies that the personal protective equipment in question is in accordance with the Regulation. They can then mark the product with the CE-marking and put it on the market.
Personal protective equipment is classified into three categories according to the risk that the protective equipment is intended to protect against. The method of assessing conformity depends on the category to which the personal protective equipment belongs.
|Description||„Simple” personal protective equipment
Personal protective equipment where it is assumed that the user can assess the protection that the protection provides against minor hazards and is definitely aware of it in a timely manner
|Neither „simple” nor „complicated” personal protective equipment||„Complicated” personal protective equipment
Personal protective equipment intended for protection against danger to life or serious permanent danger where the user can not realize the danger in time
|Issuing of Declaration of Conformity||Declaration of conformity issued under the manufacturer's responsibility||Declaration of conformity issued by the manufacturer after a type-examination certificate has been approved by a recognized body||Declaration of conformity issued by the manufacturer after the notified body has issued a type-examination certificate and after the notified body has carried out quality control of the product or control of the quality system|
This process is better described by the following flowchart.
Instructions for Use
Personal protective equipment sold in Iceland shall be accompanied by instructions for use, which are discussed in more detail in Annex I to the Regulation on the Structure of Personal Protective Equipment.
The instructions for use, which the manufacturer must draw up and provide with the personal protective equipment which they put on the market, must state the name and postal address of the manufacturer or their authorized representative established within the European Economic Area. All necessary information must be provided on:
- Storage, use, cleaning, maintenance, repair and disinfection. The substances recommended by the manufacturer for cleaning, maintenance or disinfection should not be harmful to the persona protection equipment or their users if the instructions are followed.
- The usefulness of the personal protective equipment according to the technical tests that are carried out to verify how much protection they provide or their protection category.
- Optional accessories, available with personal protective equipment, and any suitable spare parts.
- Protection suitable for different hazard levels and corresponding restrictions on use.
- The lifespan of the personal protective equipment or certain components thereof
- Appropriate transport packaging for personal protective equipment
- Significance of markings, if any (see Article 2.12 of Annex I).
- Instructions for use must be clear and comprehensible and written in at least the official language or languages of the Member State to which they are to be sent.
Information Labels for Personal Protective Equipment
A regulation on the design of personal protective equipment authorizes the affixing of information labels and other identification on personal protective equipment intended to ensure health and safety.
The labels should be in the form of standardized illustrative or graphic symbols and prescribe the defenses that they are intended to provide so that it will be understandable to most people. However, they must not cause misunderstanding or obscure the CE-marking.