Product Assurance

Product Assurance is a key component of corporate responsibility and product quality management.

Its purpose is to ensure that products, materials and technical documentation comply with applicable regulatory requirements, safety standards and the specific requirements of target markets.

A structured Product Assurance approach enables companies to:

• Improve compliance management;
• Reduce the risk of non-compliance;
• Support product commercialization and market access;
• Protect consumers and end users;
• Strengthen brand reliability and reputation;
• Facilitate access to European and international markets.

Product Assurance activities encompass regulatory, documentation, technical and analytical aspects throughout the entire product lifecycle, helping organizations ensure compliance, quality and safety from development to market placement.

CE marking demonstrates that a product complies with the essential requirements established by applicable European legislation.

By affixing the CE mark, the manufacturer declares that the product meets requirements related to:

• Safety;
• Health protection;
• Environmental protection;
• Consumer protection.

CE marking is mandatory for a wide range of products placed on the European market and requires the proper management of the technical, documentation and regulatory requirements established by the applicable directives and regulations.

TentaConsult Italia supports companies in managing the documentation and regulatory compliance processes required for placing products on the EU market, helping ensure conformity with applicable legislation and facilitating market access.

ATEX Directive – 2014/34/EU

The ATEX Directive 2014/34/EU regulates equipment and protective systems intended for use in potentially explosive atmospheres.

Its purpose is to prevent explosion risks associated with the presence of:

• Gases;
• Vapours;
• Mists;
• Combustible dusts.

Compliance with the ATEX Directive requires manufacturers to assess potential explosion hazards and ensure that products meet the applicable safety and conformity requirements before being placed on the market.

TentaConsult Italia supports companies in identifying and managing the technical, documentation and regulatory requirements applicable to products covered by the ATEX Directive.

RoHS Directive – 2011/65/EU

The RoHS Directive 2011/65/EU restricts the use of hazardous substances in electrical and electronic equipment (EEE).

The legislation aims to reduce risks to human health and the environment by limiting the presence of substances such as:

• Lead;
• Mercury;
• Cadmium;
• Hexavalent chromium;
• Brominated flame retardants.

Compliance with RoHS requirements is essential for placing electrical and electronic products on the European market and demonstrating responsible product stewardship.

TentaConsult Italia provides regulatory support and documentation review services to help companies assess and manage RoHS compliance obligations.

REACH Regulation – EC No. 1907/2006

The REACH Regulation (EC No. 1907/2006) governs the Registration, Evaluation, Authorisation and Restriction of Chemicals within the European Union.

Its objective is to ensure a high level of protection for human health and the environment through the effective management and control of chemical substances used in products and industrial processes.

REACH compliance may involve obligations relating to substance registration, communication within the supply chain, management of substances of very high concern (SVHCs), and conformity with applicable restrictions.

TentaConsult Italia supports businesses in understanding and managing REACH requirements, helping ensure regulatory compliance and reduce risks associated with chemical substances throughout the product lifecycle.

The General Product Safety Regulation (EU) 2023/988 (GPSR) establishes the general safety requirements applicable to consumer products placed on the European Union market.

The Regulation introduces specific obligations for manufacturers, importers, distributors, and online marketplace providers, strengthening requirements for product safety, traceability, and oversight throughout the entire product lifecycle.

TentaConsult Italia supports companies in achieving compliance with the GPSR through technical and regulatory consulting services, helping economic operators implement the obligations established by the Regulation.

Our services include:

• Assessment of product technical documentation;
• Verification of product identification and safety information;
• Review and integration of product risk assessments;
• Development of procedures for product management and complaint handling in accordance with the Regulation;
• Gap Analysis against GPSR requirements;

Support for documentary and organizational compliance

We assist manufacturers, importers, and distributors in managing product compliance, helping them ensure product safety, maintain complete technical documentation, and effectively fulfill their regulatory obligations.

TentaConsult Italia supports companies in reviewing and assessing technical documentation for both Food and Non-Food products.

Our services can be applied to a wide range of product categories, including:

• Cosmetics;
• Medical devices;
• Toys;
• Electrical and electronic equipment;
• Consumer products;
• Other products subject to European directives and regulations.

Our activities may include:

• Documentation review;
• Regulatory compliance assessment;
• Technical file evaluation;
• Verification of applicable regulatory requirements;
• CE marking support;
• Verification of compliance with Regulation (EU) 2023/988 (GPSR);
• Assessment of documentation completeness and consistency.

Gap Analysis and Compliance Support

We conduct Gap Analysis activities to assess the completeness of technical documentation and identify potential deficiencies against applicable regulatory requirements.

The objective is to support companies in:

• Identifying compliance gaps and non-conformities;
• Improving technical and regulatory documentation;
• Managing applicable regulatory requirements;
• Reducing compliance-related risks;
• Preparing products for market placement.

This structured approach helps organizations strengthen compliance management and improve control over product-related regulatory obligations throughout the product lifecycle.

Integrated Support Through the International Tentamus Network

As part of the Tentamus Group, TentaConsult Italia offers an integrated approach that combines regulatory consulting, documentation assessment and laboratory testing services.

This multidisciplinary support enables companies to verify product compliance with applicable European and international regulations, while benefiting from the expertise and capabilities of the wider Tentamus network.

Services may include:

• Chemical testing and analysis;
• Verification of restricted substances;
• REACH, RoHS and GPSR support;
• Compliance testing;
• Technical product assessments;
• Material and component verification;
• Regulatory and documentation support.

By integrating technical, regulatory and analytical expertise, we provide comprehensive support for the effective management of Product Assurance activities and product compliance requirements.