ISO 22716GMP for the cosmetics industry · Good Manufacturing Practice

ISO 22716 –
Cosmetics export requires certified GMP

ISO 22716 is the GMP standard for the cosmetics industry — Good Manufacturing Practice. Mandatory for exporting cosmetics to Europe (EU Cosmetics Regulation), the US (FDA) and China. CBE has been guiding Israeli cosmetics manufacturers to certification for 30 years.

CBE specializes in guiding and certifying organizations for the ISO 22716 standard, tailoring the management system to the organization's needs.

Version: ISO 22716:2007Validity: 3 years + annual auditRecognized: EU, US (FDA), ChinaSuitable for: cosmetics and personal-care manufacturing

Quick facts – ISO 22716

Goal

Good Manufacturing Practice for cosmetics

Who needs it

Manufacturers of cosmetics, personal care and beauty products

Importance in Israel

Mandatory for export to EU, US and more

Complements

ISO 9001, ISO 22000, CPNP

CBE – success rate

100% – hundreds of certified clients

What is ISO 22716?

Cosmetics to European and American standards

ISO 22716 is the international GMP standard for the cosmetics industry. It defines good cosmetics manufacturing guidelines — layout, production processes, packaging, storage, quality control and more.

EU Cosmetics Regulation (EC) 1223/2009 mandates GMP based on ISO 22716 for all cosmetics marketed in Europe. The US FDA requires equivalent GMP.

CBE doesn't just guide you to ISO 22716 — we build a framework that combines ISO 22716, ISO 9001 and CPNP (EU registration), because cosmetics export requires all of them.

GMP for cosmetics production

Production procedures, cleaning, hygiene and process control.

Raw-material quality control

Testing every raw material before use in production.

Packaging & labeling management

Meeting EU regulations for cosmetics labeling and packaging.

Product Information File

PIF — the product file for the EU regulator.

Who needs ISO 22716?

Cosmetics & personal-care manufacturers

Any cosmetics manufacturer who wants to export to the EU must hold ISO 22716.

To sector page

Natural & organic products

Natural cosmetics made in Israel — the EU market requires GMP.

Therapeutic personal care

Creams, masks and skin-care products.

To sector page

Tanning & SPF products

Sun-protection creams — FDA + ISO 22716.

Shampoo & hair products

Shampoo, conditioner and hair dyes — EU Cosmetics Regulation.

Perfumes & sprays

Perfumes and fragrance products — EU + FDA.

Benefits

What do you get from ISO 22716 certification?

Legal export to the EU

Without ISO 22716/GMP — you cannot market cosmetics in the EU

FDA Ready

A basis for meeting FDA cosmetics requirements

Protecting customers & brand

GMP protects from complaints, recalls and brand crises

CPNP Registration

GMP is a condition for CPNP registration in the EU

What does ISO 22716 require?
1

Organizational context

Defining the organization's needs, stakeholders and the scope of the quality management system.

5

Operation

Process planning and control, managing customer requirements, external providers and output control.

2

Leadership

Management commitment, quality policy and defining roles and responsibilities.

6

Performance evaluation

Measurement, analysis, internal audit and management review.

3

Planning

Risk and opportunity management, quality objectives and plans to achieve them.

7

Improvement

Managing non-conformities, corrective actions and continuous improvement of the system.

4

Support

Resources, employee competence, internal communication and documentation.

Don't know where to start?

CBE performs a full Gap Analysis and builds a work plan tailored to your organization.

The certification process with CBE

CBE accompanies you at every stage — from Gap Analysis to CPNP registration

1

Gap Analysis

Gap analysis against ISO 22716 and the EU Cosmetics Regulation

2

Building the GMP framework

Procedures, Batch Records, SOPs

3

Implementation

Applying GMP, training workers

4

Internal audit

Reviewing GMP compliance

5

Certification + CPNP

Audit + assistance with CPNP registration in Europe

Why choose CBE for ISO 22716?

30 years, hundreds of clients, 100% success — here's what sets us apart

100% success

Committed to success! No client has ever failed a certification audit. Not certified — you don't pay!

A pace that suits you

We adapt the schedule to your deadline — tender, supplier, client.

We write for you

CBE's skilled human team writes your procedures and documentation tailored to your organization.

Full GRC framework

ISO 22716 is the foundation. CBE also guides you to ISO 9001, ISO 22000, CPNP and more.

Years-long guidance

We don't disappear after the certificate. Annual audits, standard updates, organizational changes.

4,000 satisfied clients

From startup to corporation — experience with every organization type in every field.

ISO 22716 as part of a cosmetics export framework

ISO 22716 covers GMP — full export also requires CPNP registration and meeting the EU Cosmetics Regulation.

About CBE's GRC framework

FAQ about ISO 22716

A question you didn't find here?

Call for a free consultation

03-5105232

What is the EU Cosmetics Regulation?

What is CPNP?

Is ISO 22716 required in Israel too?

How long does it take to certify ISO 22716?

CBE specializes in guiding and certifying organizations for the ISO 22716 standard. The service is provided by CBE's experts, with 30 years of experience in ISO standards, over 4,000 satisfied clients and 100% success in audits.

A consultation call — at no cost and with no obligation

Tell us about your cosmetics products and what's driving you — we'll come back with an export plan

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