L10

Question 1

What are 5 potentially dangerous substances in cosmetics?

Answer 1

Parabens
Sulfates
Lead
Phthallates
Triclosan

Question 2

What are cosmetics & personal care products?

Answer 2

Those applied to human body for purposes of cleaning, perfuming, changing appearance, promoting good condition & protecting

Question 3

Why are cosmetics regulated?

Answer 3

To ensure safety of users & environment

Question 4

When did serious regulation of cosmetics occur?

Answer 4

Late 20th century

Question 5

What caused 36 infant deaths due to talc?

Answer 5

Excessive amounts of Hexachlorophene

Question 6

When was the EU cosmetics directive enacted?

Answer 6

1972

Question 7

What countries take a risk-based approach?

Answer 7

US, Canada, Australia -> recognise certain conc. levels chemicals may pose no threat to health

Question 8

What countries take a hazard based approach?

Answer 8

EU & Japan - if identified as a hazard its best to avoid those chemicals completely

Question 9

What is cosmetic classification sometimes referred to?

Answer 9

Borderline Product Classifications

Question 10

What are cosmetic products not allowed to exert?

Answer 10

Pharmalogical, metabolic or immunological action
Or be advertised as treating/preventing disease

Question 11

Can Cosmetics be ingested, implanted or inhaled?

Answer 11

No

Question 12

What are classified as medicines?

Answer 12

Lip balms, nappy ointments, mouthwashes

Question 13

What can be classified as both cosmetics & drugs simultaneously?

Answer 13

Personal care Products (PCP) eg. spf rated moisturisers

Question 14

What is the EU cosmetic Directive 1976-2013

Answer 14

Member states had to implement the EU text in their own laws

Question 15

What is the EU cosmetics regulation 1223/2009?

Answer 15

Since 2013 - single piece of legislation instantly & directly applicable across whole EU territory

Question 16

What are 2 objectives of the European Cosmetics Regulation?

Answer 16

High level of protection of human health
Facilitate function of EU single market

Question 17

What are 3 key principles of the European Cosmetics Regulation?

Answer 17

Must be safe
Manufacturer must demonstrate safety
Adequate info must be provided to consumers to allow safe use

Question 18

Define cosmetic product according to regulation text?

Answer 18

Any substance or mixture intended to be placed in contact with external parts of the human body

Question 19

When is a cosmetic product deemed safe for human health?

Answer 19

Used under normal conditions & taking into account presentation (conform with directive 87/357/EEC), labelling, instructions & any other indication

Question 20

Who is the responsible person?

Answer 20

Manufacturer or importer responsible for safety & legal compliance
Legal entity established in EU

Question 21

Can products without a responsible person be placed on the market?

Answer 21

No

Question 22

What is mandatory for the RP?

Answer 22

Statement of compliance with GMP

Question 23

Is it possible to implement & operate according to GMP standard without being formally certified?

Answer 23

Yes

Question 24

What does GMP contribute to?

Answer 24

Reproducibility
Documentation
Tracebility

Question 25

What must a RP do?

Answer 25

Establish & maintain Product Information File (PIF) made available to CA Ensure safety assessment has been performed Maintain & update PIF with relevant new data

Question 26

What are the 3 main headings in the PIF?

Answer 26

Description of CP CP safety report Manufacturing method, statement of GMP, lists of animal tests

Question 27

What is Part A of the PIF?

Answer 27

CP safety info

Question 28

What is part B of the PIF?

Answer 28

CP safety assessment

Question 29

In what way is the safety assessment performed?

Answer 29

case by case basis Weight-of-evidence approach

Question 30

Does Regulation define a fixed structure for the CP safety report? (CSPR)

Answer 30

No they describe elements

Question 31

Is data waiving possible in the CPSR?

Answer 31

Yes if justifible

Question 32

What does Article 10.2 say?

Answer 32

CP safety assessment shall be carried out by a person in possession of a diploma or relevant study

Question 33

What 3 things does the Safety assessment contain?

Answer 33

Exposure assessment Selection of appropriate toxicological endpoints as basis & justification for waiving Constitutes a weight-of-evidence risk assessment

Question 34

What are 4 sources of toxicology info & data?

Answer 34

Observations in humans Toxicity testing in animals Toxicity testing in cells in labs Other data

Question 35

What are 4 in vivo toxicity tests?

Answer 35

Acute toxicity Skin corrosion/irritation Serious eye damage Respiratory or skin sensitization

Question 36

What do CP require for placement on to the market?

Answer 36

Online filing of a single central EU notification through the Cosmetic Products Notification Portal (CPNP) by RP

Question 37

What is in the CPNP?

Answer 37

Product category Name RP Country of origin Member state where product is placed on market

Question 38

Who has access to the CPNP

Answer 38

Competent Authorities Poison Control Centres

Question 39

What are 4 substances with restrictions?

Answer 39

Colorants, UV filters - +ve list (Annex IV-VI) Specific substances of concern -banned/restricted negative lists CMR substances (carcinogenic) Nanomaterials

Question 40

When must products containing nanomaterials be notified?

Answer 40

6 months prior to placing on the market unless they are on +ve list

Question 41

When did EU regulation ban animal testing for CPs?

Answer 41

March 2013

Question 42

What 7 things have to be on the CP to inform the consumer?

Answer 42

Name & address of RP Nominal content Product durability Precautions for use Batch number Product function List of ingredients

Question 43

What nomenclature are ingredients listed in?

Answer 43

INCI (International Nomenclature of Cosmetic Ingredients)

Question 44

In what order are ingredients labelled?

Answer 44

Order of weight at time they are added (below 1% no particular order)

Question 45

What are product claims intended to do (3 things)?

Answer 45

Help consumers choose a product Foster competition Highlight innovation

Question 46

What % of product claims were verifiable when 289 product adverts were examined?

Answer 46

<18%

Question 47

How do Member states monitor compliance?

Answer 47

PIF compliance checks at RP address Physical & lab inspections

Question 48

Who communicates serious undersiable effects?

Answer 48

RP & distributors to report all SUEs which are known to them & any corrective measures

Question 49

Define undesirable effect?

Answer 49

Adverse reaction for human health attributable to normal or reasonably forseeable use of products

Question 50

Define SUEs

Answer 50

Undesirable effect resulting temporary or permanent functional incapacity, disability, hospitalization

Question 51

Are Cosmetic & PCP regulations harmonised?

Answer 51

No