Practical considerations before testing

 

Typically, tests are contracted out as a package. This has the advantage of being performed by experts in the most time-efficient manner and according to the required quality standards and legal requirements.

Remember that the outcomes of certain tests may affect the need to perform other tests.

 

Time needed

Indicative timelines for receiving the test results from a contractor are as follows:

 

Type of information Time for preparing the contract Time for testing and reporting the results  TOTAL
Physicochemical information 1 month 2 months 3 months
Environmental effects (if substance ‘readily biodegradable') 1-2 months 3 months 4-5 months
Environmental effects (if substance not ‘readily biodegradable') 1-2 months 6 months 6-7 months
Human health effects for 1-10 tonnes 2-3 months 4 months 6-7 months
Human health effects for 10-100 tonnes 2-3 months 9-11 months 11-14 months
Chemical safety assessment 2-3 months 3-12 months* 5-15 months


** depending on the conclusions of the hazard assessment and the complexity of the life cycle of the substance

It takes time to book a contract and you need to prepare for the fact that there may be a waiting time before the service provider you have chosen can take your project on board.

 

Quantity of substance needed

The composition of the substance to be tested should be representative of the one that the co-registrants manufacture or import, and as a minimum, should fit the substance identity profile (SIP) established for the joint registration.

This is so that the results of physicochemical, environmental and human health tests are relevant for a real world situation and account for the possible variability among the members of the joint submission relying on the information generated.

The indicative quantity needed for testing (assuming that all tests need to be carried out) is as follows:

 

  Physico-chemical properties Environ-mental effects Human health effects TOTAL
1-10 tonnes registration 650 gr 200 gr 140 gr Ca. 1kg
10-100 tonnes registration 650 gr 400 gr 9.2-14.2 kg
(up to over 200 kg)*
10.25-15.25 kg
(up to 215 kg)*

* depending on the route of administration because of the type of substance: 100 kg of a substance is needed for each of 1-2 inhalation tests

For detailed information on individual tests, please see Practical guide for SME managers and REACH coordinators.

 

Indicative costs for generating new information

The report “Monitoring impacts of REACH on Innovation, Competitiveness and SMEs” was published by the European Commission in 2015 and cites the 2012 CEFIC testing catalogue as its source.

IMPORTANT: The numerical values are merely provided to give registrants an illustration of the order of magnitude of the costs involved in generating new tests or studies required by 2018. They should not be considered to be set in stone when ordering and negotiating the conducting of new tests.

Note: the information does not include indicative costs to perform the required physicochemical tests.

These indicative costs should NOT be used in the following situations:

  • to level the costs of existing (already performed) studies up or down during the negotiations with your co-registrants;
  • when contracting out new tests / studies, you should request quotes from different providers to make an informed decision.

 

Information required for 1-10 tonnes registrations
Identifier in REACH -Annex VII Information requirement (Indicative) Cost of test (€) *
8.1 In vitro skin irritation/corrosion 2 580
8.2 In vitro eye irritation 1 552
8.3 In vivo skin sensitisation** 7 117
8.4.1 In vitro gene mutation in bacteria 3 465
8.5.1 Acute toxicity (oral) 1 486
9.1.1 Aquatic toxicity on invertebrates 5 232
9.1.2 Growth inhibition study aquatic plants 5 806
9.2.1.1 Ready biodegradability (if applicable) 3 705

* Source: Monitoring impacts of REACH on Innovation, Competitiveness and SMEs (2015),
p. 233-234.
** Changes to the requirements (in 2016) make the in vitro tests a column 1 information requirement.

 

Additional information required for 10-100 tonnes registrations
Identifier in REACH -Annex VIII Information requirement (Indicative) Cost of test/study (€) *
8.1.1 In vivo skin irritation** 1 535
8.2.1 In vivo eye irritation** 1 460
8.4.2 In vitro mutagenicity study in mammalian cells
Or
In vitro micronucleus study
20 080
16 518
8.4.3 In vitro gene mutation in mammalian cells
Or
in vivo gene mutation (mouse micronucleus)
17 615
12 620
8.5.2 Acute toxicity: inhalation route 12 267
8.5.3 Acute toxicity: dermal route** 2 486
8.6.1 Short-term repeated toxicity 52 925
8.7.1 Screening for reproductive/ developmental toxicity 97 120
9.1.3 Short-term toxicity on fish or testing proposal for long-term toxicity on fish (if applicable) 4 845
9.1.4 Activated sludge respiration inhibition test 3 651
9.2.2 Abiotic degradation 13 055
9.2.2.1 Hydrolysis as a function of pH
9.3.1 Adsorption/desorption screening 3 189

* Source: Monitoring impacts of REACH on Innovation, Competitiveness and SMEs (2015),
p. 233-234.
**Changes to annex requirements (in 2016) make the need to perform this test a column 2 requirement.

  • Cost of QSARs for Annex III are estimated at 1 500€, with an additional 500€ for presenting the results in the registration dossier.

  • You should consider costs related to additional assessments: expert advice for assessing the behaviour of your substance in a living organism (called toxicokinetics) has been valued at 1 278€*.

Other costs

  • You should also consider that there will be costs related to the scientific expertise necessary for preparing any adaptation, to fulfil an information requirement (e.g. weight of evidence), instead of the study itself.

  • You should reserve an additional 250-1 000€ per information requirement for the preparation of the information in the format that should be used in the registration dossier.

  • There is a need to balance all business and regulatory needs to make the best-informed decision.

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