International Approvals

  • North America

    United States

    Safety regulation in the USA is a mixture of product standards, electrical codes, fire codes (NFPA), state and national laws. Local and federal government agencies have the authority to monitor that these codes are being enforced and implemented. Two major types of standards include: OSHA (Occupational Safety and Health Administration) and ANSI (American National Standards Institute). OSHA standards are published by the state and compliance is mandatory. The OSHA standards can therefore be indirectly compared with the European directives, although there are vast differences in how the standards ( as compared to European directives) are written, interpreted and enforced. ANSI standards, on the other hand, are developed by private organizations and their application is generally not absolutely mandatory.

    Canada

    The CSA (Canadian Standards Association) are the mainapprovals body in Canada, however approvals are accepted from any OSEA member.Canadian standards must be used in order to apply for Canadian approval. OSEA laboratories can test to both U.S. and Canadian standards and can often provide a dual approval, e.g. by using standards UL508/CSA22.2 to achieve cULus or cCSAus. Approval.

  • Asia

    The three significant manufacturing countries in Asia that have safety directives are Japan, China, Russia and CIS states and their approach is broadly similar, based on certification and type approval tests through either a local or global notified body. Often these directives are reflective of both ISO and IEC standards but may not actually refer to them in the final documentation.

    Japan

    Japan has the Industrial Safety and Health Law which relates to design issues for certain machinery and plant and states that the machine operator is responsible for risk analysis and safety in the workplace. Provision of a risk analysis and confirmation that the machine has been designed safely is therefore requested at point of purchase. JIS standards (Japanese Industrial Standards) reflect the requirements of both ISO and IEC standards but the Industrial Safety and Health Law does not currently refer to them.

    Russia

    Russia operates GOST-R certification requiring that technical devices will be subject to a certification process and usually undergo a type approval test via a notified body.

    China

    China operate CCC certification in a similar vein to Russia where technical products are subject to mandatory certification through an approvals body.

    South Korea

    The Safety (Electrical) Requirement is controlled by the Ministry of Commerce, Industry and Energy (MOCIE). Most electrical products require a eK Mark Certification which supports in part, products approved via the CB scheme. ILAC accredited EU EMC Reports can be used to obtain the KC mark for EMC approval for non-radio or non-telecoms products.

  • Australia

    In Australia, states and territories have the responsibility of drafting and implementing safety laws. Fortunately the individual laws on industrial safety and their requirements are very similar. The relevant legislation is based on the Occupational Health and Safety (OH&S) Act. This defines the obligations and duty of care of people with various responsibilities. Numerous regulations and codes of practice for the various safety areas fall under the state OH&S legislation.


    The regulations are not legally binding. Neither are the codes of conduct legally binding in general. However, they are frequently consulted as a benchmark in the relevant legal system when it is necessary to assess whether sufficient measures were taken to design a safe workplace. For this reason, failure to comply with codes of conduct can have very serious consequences. Regulations sometimes refer to the codes of conduct, as well as theAustralian standards drafted by an independent organisation called "Standards Australia". However, with a few notable exceptions, Australian standards are not legally binding. Again, courts frequently consult them when it is necessary to assess whether sufficient measures were taken to reduce risks. The most important machinery safety standard in Australia is AS4024.1 for example.

    Although compliance is not mandatory, it does represent an excellent defence in case of an action relating to neglect of duty of care.Failure to comply, on the other hand, may have considerable legal consequences. Many Australian standards are based on international standards, particularly:Standards issued by the International Electro technical Commission (IEC),European standards (EN),British standards (BS, nowadays often in the form of combined BS EN standards) or Standards issued by the International Organization for Standardization (ISO). Standards Australia's official policy is to adopt international standards (ISO or IEC) where possible in the interests of international alignment. In contrast, US American standards (ANSI standards) rarely correspond to Australian, ISO or EN standards and are of little importance in Australia.

  • South America

    Brazil

    Machinery must comply with the technical and legal requirements under Regulatory Rule 12 (NR-12 - Safety At Work In Machinery And Equipment) of the Ministry of Labor and Jobs.

    NR-12 Conformity Certificates are issued typically via a notified body that provide the necessary evidence that all requirements are met.

  • European International Approvals

    European Directives are published in the Official Journal (OJ) of the European Union (EU).

    Each Directive specifies an implementation date. This is the date that identifies when use of the Directive can begin (usually a voluntary requirement).

    A Directive will also specify a date on which it becomes effective. This is the date from which compliance with the Directive becomes a mandatory
    requirement.

    The time period between the implementation date and the effective date is known as the transition period.

    European directives do not apply directly to people or products. They are directives from the EU to member governments. The individual governments have to ensure that national laws are created or amended to cover the requirements of the directives. Thus the directives are translated into national law in all member states of the European Union. An important point to note is that the exact requirements for a directive are to be found in national laws and not in the directives themselves. The result of this is that there can be differences in the interpretation or specific implementation requirements, particularly relating to documentation where something that is acceptable in one country would not be passed in another. However, once compliance has been achieved in one state, it is taken to be approved in all member states.

    New Approach Directives and the CE Mark
    In 1985 the CE Marking system was established. The requirements for CE marking are specified in the "New Approach" Directives. Directives written prior to this did not take the CE Marking into account (Known as the "global approach").

    New Approach Directives provide controls on product design and allow harmonization of product safety requirements across all 28 member states of the EU, plus the 3 countries of the European Economic Area (EEA); Iceland, Liechtenstein and Norway.

    CE Marking can only be applied to products that comply with all the applicable Directives, one or more of which must be a "New Approach" Directive.

    Application of the CE Mark indicates compliance with all relevant European Directives and allows the product to be sold without reference to national regulations.

    A official guide to the implementation of European Directives can be found on the official website of the EU:
    http://ec.europa.eu/enterprise/newapproach/legislation/guide/

    Meeting the Requirements
    Each Directive provides a set of "essential health & safety requirements" (EHSR’s). These essential requirements relate to product safety and call for a minimum level of protection against injury to persons or damage to property. EHSR’s are general in nature and do not identify specific design criteria.

    The EU develops harmonized standards known as European Norm (EN) standards. Each EN standard defines criteria for meeting essential requirements. Compliance with the applicable standard therefore infers compliance with the directive (known as presumption of compliance).

    This is not the only way to comply with the essential requirements of a Directive, but it is probably the most straightforward. In industries where the state-of the-art is ahead of the published EN standards, other standards (including ISO or a company’s own standards) may be used to demonstrate compliance with the EHSR’s of the directive. It must be stressed that this is not normally an option where a suitable EN standard exists.

    The manufacturer of the product may choose to undertake the evaluation and testing to European standards themselves if they have suitable resources and expertise available.

    The use of a Notified Body (an EU approved external test laboratory) is not normally mandatory to demonstrate compliance with most directives, although their knowledge, expertise and impartiality in assessing your product may make it advisable to do so.

    There are a small number of instances, (such as with certain types of machinery) which must be approved by a Notified Body before being placed on the market. Refer to the text of the specific Directive or contact a Notified Body for details.

    Information relating the compliance of the product (test reports, design information etc), commonly know as a "Technical File" should be stored in such a way that it can be retrieved within a reasonable amount of time if required. This information (particularly if commercially sensitive) does not need to be freely available to the public, however it must be available to anyone having reasonable cause for enquiry, such as members of H.M Trading Standards or The Health & Safety Executive (in the UK). This applies to similar, governmental organisations within the other European member states.

    Member states are restricted from hindering the free movement of goods that are properly marked – they must have a good reason for doing so, such as the investigation of an accident or a complaint involving the product. CE marked product will be assumed to comply with all applicable directives, unless it can be proved otherwise.

    EC declarations of conformity
    These documents are drawn up by the manufacturer (or representative within the EU, if the products are imported). An EC declaration must be supplied when requested.

    This declaration states:

    The name of the manufacturer
    The product(s) it refers to
    The directive(s) that it complies with
    The applicable European Standards
    References to test results
    The person responsible within the EU who is responsible for placing the product onto the market
    The year in which the declaration was first issued