Practical considerations before testing

 

Tests are normally contracted out as a package. The advantage is that the tests are performed by experts in a time-efficient manner and according to the required quality standards and legal requirements.

Remember that the outcome of certain tests may mean that you need to perform other tests.

 

Time needed

Indicative timelines for receiving the test reports 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 lab capacity and workload, these times may be longer.
** depends on the conclusions of the hazard assessment and the complexity of the life cycle of the substance.

It takes time to book a service provider and sign a contract with them. You may also have to wait before the service provider you have chosen can take your project on board.

 

Quantity of substance needed

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

This is to make sure that the results of physicochemical, environmental and human health tests are relevant for a real world situation and take into account possible variations among the members of the joint submission who rely on the same information.

Indicative quantities needed for testing (assuming that all tests need to be carried out) are as follows:

 

  Physico-chemical properties Environ-mental effects Human health effects TOTAL
1-10 tonnes registration 650 g 200 g 140 g Ca. 1kg
10-100 tonnes registration 650 g 400 g 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 based on the type of substance: 100 kg of substance is needed for each of 1-2 inhalation tests.

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

 

Indicative costs for generating new information

The below information on the indicative costs for generating new information, comes from the report 'Monitoring impacts of REACH on Innovation, Competitiveness and SMEs' published by the European Commission in 2015. The report cites the 2012 Cefic testing catalogue as their source.

The numerical values are only provided to give you an illustration of the order of magnitude of the costs involved in generating new tests in 2012.

They are for information only. Current costs may be different.

You should always request quotes from different providers to make an informed decision.

The costs below are not meant as guidance for data sharing negotiations. To share existing data, you can confirm their costs using, for example, an invoice indicating the actual cost or rely on additional considerations depending on the work carried out.

 

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 (to occur in autumn 2016) make the in vivo test a secondary requirement.

 

Information required for 10-100 tonnes registrations
Identifier in REACH -Annex VIII Information requirement (Indicative) Cost of test (€) *
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 the requirements (to occur in autumn 2016) make the in vivo test a secondary requirement.

  • Costs of (Q)SARs (e.g. for Annex III) are estimated at €1 500, with an additional €500 for documenting the results in the registration dossier.
  • 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

  • Costs to perform the required physicochemical tests, the in vitro skin sensitisation tests (not included above), and to properly identify your substance.
  • Cost to perform the combined repeated dose toxicity with the reproduction/developmental toxicity screening study, which uses a less animals than the short-term repeated toxicity study, and could be considered instead.
  • Costs related to the scientific expertise necessary to prepare any adaptation to an information requirement (e.g. weight of evidence or read-across justifications).
  • Costs for preparing the information in the right format for registration: you should reserve an additional €250-1000 per information requirement.