(MTP Ordinance No. 4219, of December 20, 2022)
SUMMARY
6.1 Objective
6.2 Scope
6.3 General provisions
6.4 Marketing and use
6.5 Responsibilities of the organization
6.6 Responsibilities of the worker
6.7 Training and information on occupational health and safety
6.8 Responsibilities of the manufacturer and importer
6.9 Certificate of Approval
6.10 Powers
6.11 Annex I – List of personal protective equipment
6.12 Glossary
6.1 Objective
6.1.1 The purpose of this Regulatory Standard (NR) is to establish the requirements for the approval, marketing, supply, and use of Personal Protective Equipment (PPE).
6.2 Scope
6.2.1 The provisions of this NR apply to organizations purchasing PPE, to workers using PPE, and to manufacturers and importers of PPE.
6.2.1.1 For the purposes of this NR, a manufacturer is a legal entity established in the national territory which manufactures the PPE, or has it designed or manufactured, assumes responsibility for its manufacture, performance, guarantee and after-sales technical assistance and sells it under its own name or trademark.
6.2.1.2 For the purposes of this NR, an importer is a legal entity established in the national territory which imports the PPE under its name or brand and assumes responsibility for the marketing, performance, warranty, and after-sales technical assistance of the PPE.
6.2.1.2.1 The importer is the purchaser of the import on behalf of a third party and the prearranged purchaser of the import to order provided for by national legislation.
6.3 General Provisions
6.3.1 For the purposes of this NR, PPE is the device or product for individual use by the worker, designed and manufactured to provide protection against the occupational risks in the workplace, as set out in Annex I.
6.3.2 Combined personal protective equipment is understood to be any equipment used by the worker that consists of several devices that the manufacturer has combined against one or more occupational hazards present in the work environment.
6.3.3 Requests for products not listed in Annex I to be considered PPE, as well as proposals for reconsideration of those listed in the Annex, shall be evaluated by the national authority responsible for occupational safety and health.
6.4 Marketing and use
6.4.1 PPE, whether manufactured domestically or imported, may be sold or used only with the Certificate of Approval (CA) issued by the national authority responsible for occupational safety and health.
6.5 Responsibilities of the organization
6.5.1 It is the responsibility of the organization to:
a) purchase only those PPE approved by the national authority responsible for occupational health and safety;
b) instruct and train workers;
c) provide the employee, free of charge, with PPE appropriate to the risk, in good condition and in working order, in the situations provided for in sub-item 1.5.5.1.2 of NR-1 General Provisions and Occupational Risk Management, considering the hierarchy of preventive measures;
d) keep a record of the PPE issued to the employee, using books, records, or an electronic system, including a biometric system;
e) require their use;
f) be responsible for disinfection and periodic maintenance, as appropriate, in accordance with the manufacturer’s or importer’s instructions;
g) replace it immediately if damaged or lost; and
h) report any irregularities observed to the national authority responsible for occupational health and safety.
6.5.1.1 The electronic system for recording the issue of PPE, if adopted, shall allow reports to be generated.
6.5.1.2 If it is not possible to record the issue of disposable PPE and protective cream, the organization shall ensure that they are made available in their original packaging in sufficient quantities for each worker at the workplace to ensure immediate supply or replacement.
6.5.1.2.1 If the original packaging is not retained, the product identification information, the name of the manufacturer or importer, the manufacturing batch, the expiry date, and the CA of the PPE shall be available at the point of supply.
6.5.1.3 The organization may establish specific procedures for the cleaning, periodic maintenance and replacement of PPE referred to in 6.5.1 (f) and (g), with appropriate information for the personnel involved, in accordance with the provisions of Section 6.7.
6.5.2 The organization shall select PPE considering:
a) the activity being performed;
b) the prevention measures based on the hazards identified and the occupational risks assessed;
c) the provisions of Annex I;
d) the effectiveness required to control exposure to the risks;
e) the requirements of regulatory standards and legislation;
f) the suitability of the equipment for the worker and the comfort provided, as assessed by all workers; and
g) compatibility, where the simultaneous use of multiple PPE is required, to ensure their respective effectiveness in protecting against the risks present.
6.5.2.1 The selection of PPE shall be recorded and may be included or referred to in the risk management program (RMP).
6.5.2.1.1 For organizations exempted from developing the Risk Management Plan, a record shall be kept of the activities carried out and the PPE used.
6.5.2.2 The selection of the PPE shall be made by the organization with the participation of the Specialized Service in Occupational Health and Safety (SESMT), if available, after hearing the user employees and the Internal Committee for Accident Prevention (CIPA) or its representative. (MTP Regulation No. 2175, of August 5, 2022 – effective as of February 2, 2023)
6.5.2.2 The selection of the PPE shall be made by the organization with the participation of the Specialized Service in Occupational Health and Safety (SESMT), if available, after hearing the user employees and the Internal Committee for Accident Prevention and Harassment (CIPA) or its representative. (MTP Regulation No. 4219, of December 20, 2022 – effective as of March 20, 2023)
6.5.2.3 The selection of PPE shall be reviewed in the situations provided for in item 1.5.4.4.6 of NR-01, if applicable.
6.5.3 The selection, use and maintenance of PPE shall also consider PPE-related programs and regulations.
6.5.4 The selection of PPE shall consider the use of over-prescription safety spectacles in conjunction with corrective lenses or the adaptation of PPE, at no cost to the worker, where the worker requires visual correction in the performance of his or her duties.
6.6 Responsibilities of the worker
6.6.1 It is the responsibility of the workers to:
a) use the PPE provided by the organization, taking into account the provisions of 6.5.2;
b) use the PPE only for its intended purpose;
c) take responsibility for cleaning, safekeeping and preservation;
d) notify the organization of any loss, damage or alteration that renders the PPE unusable; and
e) follow the organization’s instructions for proper use.
6.7 Training and information on occupational health and safety
6.7.1 The information and training referred to in this NR shall comply with the provisions of NR-01.
6.7.2 When supplying PPE, the organization shall ensure that information is provided in accordance with the recommendations of the instruction handbook supplied by the manufacturer or importer of the PPE, in particular concerning:
a) the description of the equipment and its components
b) the occupational risks against which the PPE provides protection;
c) protection limitations and restrictions
d) correct use and setting
e) maintenance and replacement; and
f) cleaning, disinfecting, safekeeping, and preservation.
6.7.2.1 The organization shall provide training on the PPE to be supplied when the characteristics of the PPE so require, considering the activity being performed and the requirements of regulatory standards and legislation.
6.8 Responsibilities of the manufacturer and importer
6.8.1 Manufacturers and importers of PPE shall:
a) market or sell only those PPE with a CA issued by the national authority responsible for occupational safety and health;
b) market PPE with instructions in the Portuguese language regarding its use, maintenance, cleaning and disinfection procedures, restrictions and other instructions for its use;
c) market PPE with the markings provided for in this standard;
d) be responsible for maintaining the quality of the PPE that has given rise to the CA; and
e) promote, when requested and if technically possible, the adaptation of PPE with a CA for persons with disabilities, preserving its effectiveness.
6.8.1.1 Information on the procedures for cleaning and disinfecting PPE shall indicate, where appropriate, the number of disinfections after which the initial level of protection is no longer guaranteed, and the equipment must be replaced.
6.8.1.2 Unless otherwise specified in the technical evaluation standard, the PPE instruction handbook may be made available in electronic form, provided that the final packaging or the PPE itself contains:
a) the description;
b) the materials of which it is composed;
c) instructions for use;
d) the level of protection provided;
e) the limitations and restrictions of the equipment; and
f) the means of electronic access to the complete instructions for use.
6.9 Certificate of Approval (CA)
6.9.1 The procedures for issuing and renewing CAs are set out in regulations issued by the national authority responsible for occupational health and safety.
6.9.2 The CA granted to PPE is valid for the duration of the conformity assessment as defined in the regulation issued by the national authority responsible for occupational safety and health.
6.9.2.1 PPE shall be placed on the market with a valid CA.
6.9.2.1.1 After purchase, the supply of PPE shall comply with the storage conditions and the expiry date of the equipment specified by the manufacturer or importer.
6.9.3 All PPE shall be indelibly, legibly, and visibly marked with the manufacturer’s or importer’s trade name, production batch and CA number.
6.9.3.1 If it is impossible to comply with the requirements of 6.9.3, an alternative form of marking may be approved and shall appear on the CA.
6.9.4 It is prohibited to transfer the use of a CA issued to a particular manufacturer or importer so that another manufacturer or importer can use it without going through the normal procedure for obtaining its own CA, except in the case of head offices and subsidiaries.
6.9.5 The adaptation of PPE for use by persons with disabilities by the manufacturer or importer holding the CA in accordance with 6.8.1 does not invalidate the certificate already issued and it is not necessary to issue a new CA.
6.10 Powers
6.10.1 It is the responsibility of the national authority responsible for occupational health and safety to:
a) establish regulations for the approval of PPE;
b) issue or renew the CA;
c) inspect the quality of PPE;
d) request PPE samples from the regional authority responsible for occupational safety and health; and
e) suspend and revoke the CA.
6.10.1.1 If irregularities are found or in the case of a justified complaint, the national authority responsible for occupational safety and health may request PPE samples from the manufacturer or importer.
Annex I – List of Personal Protective Equipment
Glossary
Buyer of the import on behalf of a third party: the legal entity that, in its own name and with its own resources, carries out the commercial transaction of buying and selling the goods abroad and engages the importer on behalf of a third party to carry out the customs clearance of the import.
PPE approval: Issuance of the CA by the national authority responsible for occupational health and safety.
Conformity assessment: demonstration that the specified requirements are met.
Certificate of approval: document issued by the national authority responsible for occupational safety and health, authorizing the sale and use of PPE within the national territory.
Predetermined buyer: The legal entity that engages the Importer on a commission basis to conduct the commercial transaction of buying and selling foreign goods to be imported, customs clearance of imports, and resale to the Predetermined Buyer.
Sanitization: Removal of contaminants that require special care or procedures. It includes the processes of decontamination and disinfection.
Cleaning: The manual or mechanical removal of dirt and residue using commonly used products such as water, detergent, soap, or disinfectant.
Trade name: For the purposes of this NR, the trade name is the company name or fictitious name listed in the National Register of Legal Entities (CNPJ), issued by the Brazilian Federal Tax Service, or a registered trademark held by the manufacturer or importer of the PPE.
Biometric system: For the purposes of this NR, it is the system that analyzes physical characteristics to uniquely identify an individual, such as fingerprint, facial recognition, and iris.