Form 1: NOTIFICATION OF SERIOUS UNDESIRABLE EFFECTS BY

A RESPONSIBLE PERSON OR A DISTRIBUTOR TO COMPETENT

AUTHORITY
According to The Cosmetic Products Enforcement Regulations 2013 as amended by The Product
Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019

Please email completed form and any attachments to seriousundesirableeffects@beis.gov.uk

If you are completing this form by hand please write legibly in BLOCK CAPITALS.

1) Case Report:

Company Report Number

Competent Authority Code

Number

Type of Report Initial Follow up Final

Date received by company

Date notified to Competent

Authority

2) Company:

Company’s role Distributor Responsible Person

Company name

Address and local contact

details

3) Seriousness criteria:

Temporary or permanent
Disability Hospitalisation
functional incapacity
Congenital anomalies Death Immediate vital risk

4) Primary reporter:

Consumer Health Professional Other

Has the reported information been

Yes No
confirmed by a medical professional?

5) End user:

Code Age

Gender Female Male Non-binary Not known

6) Suspected product:

Full name of suspected

product

Company

Category of product

Batch number

Notification number

7) Use of product:

Date of first ever use

Frequency of use times per

Professional use Yes No

Application site

Product use stopped Yes No Not Not

 known Applicable

Date of stopping the

product use

Positive Not performed

Re-exposure to the
suspected product
Negative Not known

Other suspected cosmetic

products used at the same
time

Complementary information can be attached to the document/ related in the narrative

8) Description of serious undesirable effect:

Type of effect

Date of onset

Country of occurrence

Time from the beginning of

use to onset of first
symptoms

Time from last use to

onset of first symptoms

Reported signs/symptoms

Reported diagnosis if any

9) Location of the serious undesirable effect:

Skin area(s) concerned: Scalp Hair

Eyes Teeth Nails Lips

Mucosae, specify

Others, please specify

SUE in area of product

application
SUE outside area of product
application

10) Outcome of serious undesirable effect:

Recovered

Improving

After effects

Ongoing

Unknown

Other

11) Relevant underlying conditions:

Any relevant underlying conditions Yes No

If yes, please specify

Additional concurrent use of other products Yes No

If yes, please specify

12) Relevant medical information/history:

Allergic diseases Yes No

If yes, please specify

Cutaneous diseases Yes No

If yes, please specify

Other relevant underlying diseases Yes No

If yes, please specify

Skin specificities including phototype Yes No

If yes, please specify

Others (example, specific climatic

Yes No
conditions or specific exposure)

If yes, please specify

13) Case management:

Treatment of the serious undesirable effect

Name of prescribed drugs

Dosage

Duration

Any other measures? Yes No

If yes, please specify

Seriousness of undesirable effect

Functional incapacity Yes No

If yes, please specify

Were the effects temporary? Yes No

If temporary, please specify duration

Expert evaluation available Yes No

Medical certificate available Yes No

Corrective treatment of the functional

incapacity

Disability

Please specify the %

Description

Expert evaluation available Yes No

Medical certificate available Yes No

Hospitalisation

Hospital name and address

Duration of hospitalisation

Corrective treatment received during time in

Yes No
hospital

If yes, please specify:

Drug prescription

Dosage

Duration

Treatment/measures taken after

hospitalisation

Congenital abnormalities

Detected during pregnancy Yes No

Detected after delivery Yes No

Expert evaluation available Yes No

Immediate vital risk Yes No

If yes, please specify treatment and specific

measures

Death

Date of death

Please specify diagnosis

Death certificate available Yes No

14) Complementary investigations:

Any complementary investigations? Yes No

If yes, please specify details

Allergy testing? Yes No

15) Summary from Responsible Person or Distributor:

Narrative

Follow up

Specify Competent Authority case

identification number (if available)

Causality Assessment:

Very likely

Likely

Not clearly attributable

Unlikely

Excluded

Not assessable

Management:

Has this case previously been submitted to Not

Yes No
a Competent Authority? known

Have any corrective actions been taken? Yes No

If yes, please specify